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Comunicado de la FDA sobre la seguridad de los medicamentos

Comunicado de la FDA sobre la seguridad de los medicamentos: Casos poco comunes de quemaduras graves con el uso de analgésicos tópicos de venta libre para el dolor muscular y articular Anuncio de seguridad Información adicional para consumidores Información adicional para profesionales de la salud Resumen de datos Fuentes 13 de septiembre del 2012. La Administración de Alimentos y Medicamentos de Estados (FDA por sus siglas en inglés) cumple con avisar al público que se ha reportado que, en casos pocos comunes, ciertos productos de venta libre que se aplican sobre la piel para el alivio de dolor muscular y articular leve causan lesiones graves de la piel, quemaduras químicas que van de primer a tercer grado, que ocurren en el punto en que se aplican los productos. Estos analgésicos tópicos de venta libre para el dolor muscular y articular están disponibles a manera de productos de ingrediente único o una combinación de ingredientes que contienen mentol, salicilato de metilo o capsaicina. Las diversas presentaciones incluyen cremas, lociones, ungüentos y parches. Datos sobre los analgésicos tópicos sin receta para el dolor muscular y articular | - Se usan para aliviar temporalmente el malestar y dolor muscular y articular - Se venden bajo diferentes marcas como Bengay, Capzasin, Flexall, Icy Hot y Mentholatum. | Cuando se aplican a la piel, los productos producen una sensación localizada de calor o frío; no deben causar dolor o daño a la piel. Sin embargo, ha habido casos poco comunes de quemaduras graves después de su uso (ver el Resumen de datos [Hipervínculo] al final de este anuncio). Con algunas de las quemaduras hubo complicaciones graves que requirieron hospitalización. En muchos casos, las quemaduras se produjeron después de una sola aplicación del analgésico tópico de venta libre para el dolor muscular y articular, y se produjeron graves quemaduras o ampollas dentro de las 24 horas de la primera aplicación. En base a los casos reportados, la mayoría de las quemaduras de segundo y tercer grado ocurrieron con el uso de productos que contienen mentol como ingrediente activo y productos que contienen mentol junto con salicilato de metilo, en concentraciones superiores a 3% de mentol y 10% de salicilato de metilo. Se reportaron pocos casos con el uso de productos que contienen capsaicina Los consumidores que usan analgésicos tópicos de venta libre para el dolor muscular y articular que presenten indicios de lesiones en la piel en el punto de aplicación del producto, como dolor, hinchazón o ampollas en la piel, deben dejar de usar el producto y solicitar atención médica inmediatamente. Información adicional para consumidores - Se han reportado casos poco comunes de quemaduras graves que se producen en la piel donde se aplicaron analgésicos tópicos de venta libre para el dolor muscular y articular. Estos productos contienen mentol, salicilato de metilo o capsaicina como ingredientes activos. - Entre las quemaduras reportadas, la mayoría de las de segundo y tercer grado ocurrieron con productos que contienen mentol como ingrediente activo único y productos que contienen mentol junto con salicilato de metilo, en concentraciones superiores a 3% de mentol y 10% de salicilato de metilo. Se reportaron pocos casos con el uso de productos que contienen capsaicina. Con algunas de las quemaduras hubo complicaciones graves que requirieron hospitalización. - La FDA evaluó recientemente las lesiones de la piel descritas. La actual Monografía Provisional Final no requiere en este momento que las etiquetas de analgésicos tópicos de venta libre para dolor muscular y articular adviertan que el uso de los productos podría producir quemaduras graves. - Si siente dolor, hinchazón o ampollas en la piel donde se ha aplicado un analgésico tópico de venta libre para el dolor muscular y articular, deje de usar el producto y solicite atención médica inmediatamente. Estos productos no deben causar dolor o daño a la piel. Estos productos producen calor o frío localizado. - Cuando se aplique un analgésico tópico de venta libre para el dolor muscular y articular en la piel, no coloque una venda apretada ni aplique calor local (mantas eléctricas, lámparas, bolsas o botellas de agua caliente) en el punto de aplicación, porque eso puede aumentar el riesgo de quemaduras graves - No aplique analgésicos tópicos de venta libre para el dolor muscular y articular en heridas o piel golpeada, quebrada o irritada. Tampoco deje que entre en contacto con los ojos y las membranas mucosas (como la piel dentro de la nariz, boca u órganos genitales). - Si tiene cualquier pregunta o inquietud sobre los analgésicos tópicos de venta libre para el dolor muscular y articular, consulte con un profesional de la salud. - Reporte efectos secundarios del uso de analgésicos tópicos de venta libre para el dolor muscular y articular al programa MedWatch de la FDA utilizando la información en el recuadro "Contact FDA" en la parte inferior de la página. Información adicional para profesionales de la salud - Se han reportado casos poco comunes de quemaduras graves que se producen en la piel donde se aplicaron analgésicos tópicos de venta libre para el dolor muscular y articular. Estos productos contienen mentol, salicilato de metilo o capsaicina como ingredientes activos. - Entre las quemaduras reportadas, la mayoría de las de segundo y tercer grado ocurrieron con productos que contienen mentol como ingrediente activo único y productos que contienen mentol junto con salicilato de metilo, en concentraciones superiores a 3% de mentol y 10% de salicilato de metilo. Se reportaron pocos casos con el uso de productos que contienen capsaicina. - Cuando recomiende un analgésico tópico de venta libre para el dolor muscular y articular a los pacientes, indíqueles cómo utilizar adecuadamente los productos e infórmeles sobre el riesgo de quemaduras graves. La FDA evaluó recientemente las lesiones de piel descritas. La actual Monografía Provisional Final no requiere en este momento que las etiquetas de analgésicos tópicos de venta libre para dolor muscular y articular adviertan que el uso de los productos pueden producir quemaduras graves. - Si un paciente tiene dolor, hinchazón o ampollas en la piel en el punto en que se aplicó un analgésico tópico de venta libre para dolor muscular y articular, aconséjele al paciente que deje de usar el producto. - Reporte efectos secundarios del uso de analgésicos tópicos de venta libre para el dolor muscular y articular al programa MedWatch de la FDA utilizando la información en el recuadro "Contact FDA" en la parte inferior de la página Resumen de datos En una búsqueda de la base de datos del Sistema de Informes sobre Eventos Adversos (Adverse Events Reporting System o AERS) de la FDA (de 1969 al 21 de abril, 2011), la base de datos (del 2004 al 2010) del Sistema Electrónico Nacional de Control de Lesiones – Programa de Cooperación para el Control de Eventos Adversos de Medicamentos (National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance o NEISS-CADES) y la literatura1 médica se identificaron 43 casos de quemaduras en el punto de aplicación asociados con el uso de analgésicos tópicos de venta libre para dolor muscular y articular que contienen mentol, salicilato de metilo o capsaicina como ingredientes activos. Los productos asociados con estos casos incluyen parches, ungüentos y cremas. Todos los casos de esta serie incluyen quemaduras que fueron confirmadas por un profesional de la salud. En los casos de esta serie, hubo informes de quemaduras de primer a tercer grado, pero en muchos casos no se especificó la gravedad de la quemadura. Muchos casos se produjeron tras una sola aplicación de un analgésico tópico de venta libre para dolor muscular y articular, con quemaduras graves o ampollas que se presentaron dentro de las 24 horas de la primera aplicación del producto. La mayoría de las quemaduras reportadas de segundo y tercer grado ocurrieron con el uso de productos que contienen mentol como ingrediente activo único y productos que contienen mentol junto con salicilato de metilo, en los que la concentración de ingredientes era superior a 3% de mentol y 10% de salicilato de metilo. Se reportaron pocos casos con el uso de productos que contienen capsaicina. Fuentes - Heng MC. Local necrosis and interstitial nephritis due to topical methyl salicylate and menthol. Cutis 1987;39:442-4. | La FDA reconoce la importancia de proveer información relacionada a la seguridad de medicamentos en otros idiomas además del inglés. Haremos nuestro mejor esfuerzo para proveer versiones de nuestras comunicaciones de seguridad de medicamentos en español que sean precisas y oportunas. Sin embargo, de haber alguna discrepancia entre la versión en inglés y la versión en español, la versión en inglés debe ser considerada la versión oficial. Si usted tiene cualesquier pregunta o desea hacer algún comentario, favor de ponerse en contacto con Division of Drug Information en druginfo@fda.hhs.gov. | Contáctenos Para informar de un problema serio 1-800-332-1088 1-800-FDA-0178 Fax MedWatch Online Corrreo normal: Use el formulario pre franqueado FDA Form 3500B Enviar por correo a: MedWatch 5600 Fishers Lane Rockville, MD 20857 |

FDA Drug Safety Communication: FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)

The FDA has issued new information about this safety issue, see the FDA Drug Safety Communication issued on 12-20-2017. This safety review update is in follow-up to the FDA Drug Safety Communication on LABAs on 06/02/2010 [04-15-2011] To further evaluate the safety of Long-Acting Beta-Agonists (LABAs) when used in combination with inhaled corticosteroids for the treatment of asthma, the U.S. Food and Drug Administration (FDA) is requiring the manufacturers of LABAs to conduct five randomized, double-blind, controlled clinical trials comparing the addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone. Four clinical trials will be conducted in adult and adolescent patients 12 years of age and older. The adult and adolescent trials will include 11,700 patients in each trial for a total of 46,800 patients. Each trial will evaluate one of the following LABA-containing drugs: 1) Symbicort (budesonide and formoterol); 2) Advair Diskus (fluticasone and salmeterol); 3) Dulera (mometasone and formoterol); and 4) Foradil (formoterol). The Foradil trial will also include treatment with fluticasone, which will be provided in a separate inhaler. One clinical trial will be conducted in pediatric patients aged 4 to 11 years with Advair Diskus. The pediatric trial will include 6,200 patients. Patients in all trials will be treated for six months, and the primary endpoint will be a composite of serious asthma outcomes: asthma-related death, intubation, or hospitalization. The pediatric trial will also assess other relevant quality of life endpoints such as days of school missed and emergency room visits because of asthma related illness. The clinical trials will begin in 2011 and FDA expects to receive results in 2017. Related Information

Increased heart risk with lamotrigine in patients with heart disease

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease FDA now requiring studies to evaluate heart risk across the drug class Español 药物安全通讯 Drug Safety Podcast Drug Safety Communication (PDF - 105KB) 03-31-2021 FDA Drug Safety Communication A U.S. Food and Drug Administration (FDA) review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine lamotrigine (Lamictal). We want to evaluate whether other medicines in the same drug class have similar effects on the heart and are requiring safety studies on those also. We will update the public when additional information from these studies becomes available. FDA required these studies, called in vitro studies, to further investigate Lamictal’s effects on the heart after we received reports of abnormal electrocardiographic (ECG) findings and some other serious problems. In some cases, problems including chest pain, loss of consciousness, and cardiac arrest occurred. In vitro studies are studies done in test tubes or petri dishes and not in people or animals. We first added information about this risk to the lamotrigine prescribing information and Medication Guides in October 2020, which we have updated. Lamotrigine is used alone or with other medicines to treat seizures in patients 2 years and older. It may also be used as maintenance treatment in patients with the mental health condition bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania. Lamotrigine has been approved and on the market for more than 25 years and is available under the brand name Lamictal and as generics. Patients should not stop taking your medicine without first talking to your prescriber because stopping lamotrigine can lead to uncontrolled seizures, or new or worsening mental health problems. Contact your health care professional right away or go to an emergency room if you experience an abnormal heart rate or irregular rhythm, or symptoms such as a racing heartbeat, skipped or slow heartbeat, shortness of breath, dizziness, or fainting. Health care professionals should assess whether the potential benefits of lamotrigine outweigh the potential risk of arrhythmias for each patient. Laboratory testing performed at therapeutically relevant concentrations has shown that lamotrigine can increase the risk of serious arrhythmias, which can be life-threatening, in patients with clinically important structural or functional heart disorders. Clinically important structural and functional heart disorders include heart failure, valvular heart disease, congenital heart disease, conduction system disease, ventricular arrhythmias, cardiac channelopathies such as Brugada syndrome, clinically important ischemic heart disease, or multiple risk factors for coronary artery disease. The risk of arrhythmias may increase further if used in combination with other medicines that block sodium channels in the heart. Other sodium channel blockers approved for epilepsy, bipolar disorder, and other indications should not be considered safer alternatives to lamotrigine in the absence of additional information (see List of Sodium Channel Blockers Required to Conduct Postmarket Studies). We previously communicated safety information associated with lamotrigine in April 2018 (serious immune system reaction), August 2010 (aseptic meningitis warning), and September 2006 (possible association between Lamictal exposure during pregnancy and oral clefts in newborns). Lamotrigine was also covered as part of a May 2009 safety alert concerning suicidal thoughts and behavior with the entire class of anti-seizure medicines. All medicines have side effects even when used correctly as prescribed. It is important to know that people respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors. As a result, we cannot determine how likely it is that someone will experience these side effects when taking lamotrigine. Your health care professionals know you best, so talk to them if you have questions or concerns. To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving lamotrigine or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page. Health care professionals, patients, and consumers can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of interest to you. | Generic Name | Brand Name | |---|---| | Carbamazepine | Carbatrol, Carnexiv, Equetro, Tegretol, Tegretol XR | | Cenobamate | Xcopri | | Eslicarbazepine | Aptiom | | Fosphenytoin | Cerebyx, Sesquient | | Lacosamide | Vimpat | | Oxcarbazepine | Oxtellar XR, Trileptal | | Phenytoin | Dilantin-125 | | Rufinamide | Banzel | | Topiramate | Qsymia, Qudexy XR, Topamax, Trokendi XR | | Zonisamide | Zonegran | Related Information - Arrhythmia - Seizures - The Facts on Bipolar Disorder and FDA-approved Treatments - The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective - Think It Through: Managing the Benefits and Risks of Medicines Contact FDA For More Info 855-543-DRUG (3784) and press 4 druginfo@fda.hhs.gov Report a Serious Problem to MedWatch Complete and submit the report Online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Generic Drugs Forum (GDF) 2026

Forum | Mixed Event Title Generic Drugs Forum (GDF) 2026 April 22 - 23, 2026 - Date: - April 22 - 23, 2026 - Day1: - Wed, Apr 22 9:00 a.m. - 05:25 p.m. ET - Day2: - Thu, Apr 23 9:00 a.m. - 05:00 p.m. ET - Location: - Event LocationAttend In Person or Online Virtual: Via Adobe Connect In Person: FDA White Oak Campus 10903 New Hampshire Ave, Building 31 The Great Room Silver Spring, MD 20903 United States Visit CDER Small Business and Industry Assistance (SBIA) Homepage Keynote Speakers Darby Kozak, PhD Deputy Director Office of Generic Drugs CDER | FDA Susan Rosencrance, PhD Deputy Director for Science Office of Pharmaceutical Quality CDER | FDA About this Event (Hosted by CDER SBIA) The annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance. Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles. The forum's primary goal is to support prospective and current applicants in submitting complete and high-quality submissions, ultimately ensuring timely access to affordable medications that benefit public health. Intended Audience The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who are: - Involved in generic drug development - Submitting or have submitted a generic drug application, amendment, supplement, or post-approval submission Topics Covered - Controlled Correspondence - Pre-ANDA Submissions and Meetings - ANDA Submissions, Assessments, and Meetings - Quality and Manufacturing - Drug Master Files - Advanced Topics and Case Studies - …Many others Continuing Education (CE) Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event. This course has been pre-approved by: - RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion. - SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. - SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration. - ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material. Resources - GDUFA guidances - Manual of Policies & Procedures (MAPPs), which are documents that describe internal policies and procedures that are made available to the public to increase transparency, on its MAPP website - Other helpful information, including recorded webinars on GDUFA topics, can be found on FDA’s GDUFA III website - Specific questions regarding the development of a generic drug product not yet submitted in an ANDA: please submit a controlled correspondence More Information Food and Drink - Public meeting attendees may bring their own food and drink as campus access is restricted to the immediate meeting area - For this event, light refreshments, sandwiches/wraps/salads are available for pre-order during the registration process. Payment will be made when the order is picked up on site - Lunch selections must be made at time of registration. Changes cannot be accommodated after registration is complete - Restaurants near the FDA White Oak campus are available. Before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.

Updated information on 32 mg intravenous ondansetron dose

FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products Safety Announcement Table 1. List of ondansetron products to be voluntarily withdrawn from the U.S. market Reference Safety Announcement [12-4-2012] The U.S. Food and Drug Administration (FDA) is notifying health care professionals that the 32 mg, single intravenous (IV) dose of the anti-nausea drug Zofran (ondansetron hydrochloride) will no longer be marketed because of the potential for serious cardiac risks. This dose has been removed from the Zofran drug label. FDA is now working with the manufacturers of all 32 mg dose ondansetron injectable products (brand and generic) to voluntarily recall them from the market. These drugs are sold pre-mixed in solutions of either dextrose or sodium chloride in plastic containers (See Table 1). A previous Drug Safety Communication (DSC), issued on June 29, 2012, communicated that the 32 mg, single IV dose should be avoided due to the risk of a specific type of irregular heart rhythm called QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm. The 32 mg, single IV dose had been used to prevent chemotherapy-induced nausea and vomiting. As stated in the previous DSC, FDA continues to recommend the intravenous regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. If the calculated weight-based dose were to exceed 16 mg, the potential for prolonged QT interval would be greater; therefore, no single intravenous dose should exceed 16 mg. In addition, oral dosing of ondansetron remains effective for the prevention of chemotherapy-induced nausea and vomiting. At this time, there is not enough information available for FDA to recommend an alternative single IV dose regimen. FDA anticipates these products (see Table 1, below) to be removed from the market through early 2013. FDA does not anticipate that removal of the 32 mg intravenous dose of ondansetron currently sold as pre-mixed injections will contribute to a drug shortage of IV ondansetron, as the 32 mg dose makes up a very small percentage of the current market. According to sales distribution data, ondansetron IV 32 mg premixed bags accounted for less than 1% of ondansetron IV sales (vials, bags, etc.) from the manufacturers to retail and non-retail channels of distribution in the 12-month period ending in June 2012.1 Table 1. List of ondansetron products to be voluntarily withdrawn from the U.S. market | Generic name | Sponsor | Application Number | |---|---|---| | Ondansetron Hydrochloride Injection, USP premix in Intravia Plastic Container | Baxter Healthcare Corporation | NDA 021915 | | Ondansetron Hydrochloride and Dextrose in Plastic Container | Hospira | ANDA 077348 | | Ondansetron Hydrochloride and Dextrose in Plastic Container | Teva | ANDA 077480 | | Ondansetron Hydrochloride and Dextrose in Plastic Container | Bedford Labs | ANDA 078291 | | Ondansetron Hydrochloride and Dextrose in Plastic Container | Claris Lifesciences | ANDA 078308 | Reference - Source: IMS Health, IMS National Sales Perspectives™. July 2011-June 2012. Extracted Nov 2012. Related Information - FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran) - FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron) - Ondansetron (marketed as Zofran) Prescribing and Label Information4 - Ondansetron (marketed as Zofran) Information - FDA Drug Safety Podcast: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products - Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la dosis intravenosa de 32 mg de ondansetrÃn (Zofran) y productos previamente mezclados de ondansetrÃn

Comunicado de la FDA sobre la seguridad de los medicamentos

Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la dosis intravenosa de 32 mg de ondansetrón (Zofran) y productos previamente mezclados de ondansetrón Esta actualización se hace a manera de seguimiento al Comunicado sobre la seguridad de los medicamentos de la FDA: Nueva información sobre la prolongación del intervalo QT con ondansetrón (Zofran) del 29/6/2012. [enlace http://www.fda.gov/Drugs/DrugSafety/ucm310190.htm] [12-5-12] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) notificó a los profesionales de la salud que ya no se comercializará la dosis intravenosa de 32 mg de Zofran (hidrocloruro de ondansetrón), un medicamento para prevenir las náuseas, debido al potencial de serios riesgos para el corazón. Esta dosis ha sido eliminada de la etiqueta del medicamento Zofran. La FDA está trabajando con los fabricantes de todos los productos inyectables (de marca y genéricos) de la dosis de 32 mg de ondansetrón para que los retiren voluntariamente del mercado. Estos medicamentos se venden premezclados en soluciones de dextrosa o cloruro de sodio en recipientes de plástico (Ver Cuadro 1). Un comunicado previo sobre la seguridad de los medicamentos emitido el 29 de junio del 2012, indicó que se debe evitar una sola dosis intravenosa de 32 mg debido al riesgo de un tipo específico de ritmo cardiaco irregular llamado prolongación del intervalo QT, que puede resultar en Torsades de Pointes, un ritmo cardiaco anormal y potencialmente fatal. Una sola dosis intravenosa de 32 mg se ha estado usando para prevenir náuseas y vómitos inducidos por la quimioterapia. Como se indicó en el comunicado anterior, la FDA continúa recomendando el régimen intravenoso de tres dosis de 0.15 mg/kg, administradas cada 4 horas, para prevenir las náuseas y vómitos inducidos por la quimioterapia. Si la dosis calculada en base al peso es superior a 16 mg, el potencial de la prolongación del intervalo QT es mayor; por lo tanto, ninguna dosis intravenosa debe exceder los 16 mg. Además, la dosis oral de ondansetrón sigue siendo eficaz para prevenir náuseas y vómitos inducidos por quimioterapia. [Zofran label] En este momento, no hay suficiente información disponible para que la FDA recomiende un régimen alternativo con una sola dosis intravenosa. La FDA tiene previsto que se retiren estos productos del mercado (Ver el Cuadro 1 a continuación) a principios del 2013, a más tardar. La FDA no prevé que el retiro de la dosis intravenosa de 32 mg de ondansetrón que actualmente se vende a manera de inyecciones premezcladas contribuya a una escasez del medicamento ondansetrón intravenoso, ya que la dosis de 32 mg representa una porción muy baja del mercado actual. Según datos de distribución de ventas, las bolsas de 32 miligramos de ondansetrón intravenoso premezclado constituyeron menos del 1% de las ventas de ondansetrón intravenoso (frascos, bolsas, etc.) por los fabricantes a canales de distribución de ventas al por menor y de otro tipo en el período de 12 meses que concluyó en junio del 2012.1 Cuadro 1. Lista de productos de ondansetrón que se retirarán voluntariamente del mercado de Estados Unidos. | Nombre genérico | Patrocinador | Número de solicitud | |---|---|---| | Inyección de hidrocloruro de ondansetrón, premezclada conforme a USP en envase de plástico de Intravia | Baxter Healthcare Corporation | NDA 021915 | | Hidrocloruro de ondansetrón y dextrosa en envase de plástico | Hospira | ANDA 077348 | | Hidrocloruro de ondansetrón y dextrosa en envase de plástico | Teva | ANDA 077480 | | Hidrocloruro de ondansetrón y dextrosa en envase de plástico | Bedford Labs | ANDA 078291 | | Hidrocloruro de ondansetrón y dextrosa en envase de plástico | Claris Lifesciences | ANDA 078308 | Referencia - 1. Fuente: IMS Health, IMS National Sales Perspectives™. Julio 2011-Junio 2012. Extraído en Nov 2012. | La FDA reconoce la importancia de proveer información relacionada a la seguridad de medicamentos en otros idiomas además del inglés. Haremos nuestro mejor esfuerzo para proveer versiones de nuestras comunicaciones de seguridad de medicamentos en español que sean precisas y oportunas. Sin embargo, de haber alguna discrepancia entre la versión en inglés y la versión en español, la versión en inglés debe ser considerada la versión oficial. Si usted tiene cualesquier pregunta o desea hacer algún comentario, favor de ponerse en contacto con Division of Drug Information en druginfo@fda.hhs.gov. | Contáctenos Para informar de un problema serio 1-800-332-1088 1-800-FDA-0178 Fax MedWatch Online Correo normal: Use el formulario pre franqueado FDA Form 3500B Enviar por correo a: MedWatch 5600 Fishers Lane Rockville, MD 20857 | Información relacionada (en inglés) - FDA Drug Safety Communication: Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed ondansetron products - FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran) - FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron) - Ondansetron (marketed as Zofran) Prescribing and Label Information - Ondansetron (marketed as Zofran) Information

Abnormal heart rhythms may be associated with use of Zofran

FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron) Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary [09-15-2011] The U.S. Food and Drug Administration (FDA) is informing the public of an ongoing safety review of the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and their generics). Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm. Facts about Zofran (ondansetron and ondansetron hydrochloride) | - Used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. - Is in a class of medications called 5-HT3 receptor antagonists. Works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.1 - Available as 4 mg and 8 mg tablets, 4 mg and 8 mg orally disintegrating tablets, and oral solution (4 mg/5 mL). Also available as an injection for intravenous use (2 mg/mL). | Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) — see Data Summary below — can lead to an abnormal and potentially fatal heart rhythm (including Torsade de Pointes). Patients at particular risk for developing Torsade include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation. FDA has reviewed all available information and is making interim changes to the drug labels. The manufacturer of Zofran (GlaxoSmithKline) is being required to conduct a thorough QT study to assess the potential for the drug to prolong the QT interval. The results from this study are expected to be available in the summer of 2012. Additional label changes may result after the additional information has been reviewed. The Zofran (ondansetron) drug labels already contain information about the potential for QT prolongation. The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Additionally, recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being included in the labels. Additional Information for Patients - Do not stop taking Zofran (ondansetron) without talking to your healthcare professional. - Discuss any questions or concerns about Zofran (ondansetron) with your healthcare professional. - While taking Zofran (ondansetron), your healthcare professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm. - Seek immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking Zofran (ondansetron). - Report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page. Additional Information for Healthcare Professionals - ECG changes including QT interval prolongation have been seen in patients receiving Zofran (ondansetron). In addition, Torsade de Pointes, an abnormal heart rhythm, has been reported in some patients receiving ondansetron. - The use of Zofran (ondansetron) should be avoided in patients with congenital long QT syndrome. - ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval. - Advise patients to contact a healthcare professional immediately if they experience signs and symptoms of an abnormal heart rate or rhythm while taking Zofran (ondansetron). - Report adverse events involving Zofran (ondansetron) to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page. The FDA previously noted cardiovascular safety concerns that suggested Zofran (ondansetron) could cause QT prolongation, which can lead to a serious and sometimes fatal heart rhythm called Torsade de Pointes. Additionally, there are articles published in the medical literature that describe QT interval prolongation with ondansetron or droperidol.2-4 FDA is now adding a new warning to avoid the use of ondansetron in patients with congenital long QT syndrome because these patients are at particular risk for developing Torsade. Previous versions of the ondansetron labels included a warning on ECG interval changes (QT interval prolongation). Additional recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being added to the ondansetron drug labels. To further characterize this risk, FDA is requiring GlaxoSmithKline to conduct a thorough QT study to determine the degree to which Zofran (ondansetron) may cause QT interval prolongation. The FDA will continue to assess all available data supporting the safety and effectiveness of ondansetron and will update the public when more information becomes available. - National Center for Biotechnology Information. U.S. National Library of Medicine. PubMed Drug & Supplements Monograph Ondansetron. Available at: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601209.html. Accessed September 10, 2011. - Charbit et al. Droperidol and ondansetron-induced QT interval prolongation. Anesthesiology 2008; 109(2): 206-212. - Charbit et al. Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron. Anesthesiology 2005; 102(6): 1094-1100. - Nathan et al. Implicationa of Anesthesia in Children with Long QT syndrome. Anesthesia and Analgesia 2011; 112(5): 1163-1168. Related Information - FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran) - Ondansetron (marketed as Zofran) Information - MedlinePlus: Ondansetron - FDA Drug Safety Communication for Healthcare Professionals: Abnormal heart rhythms may be associated with use of Zofran (ondansetron) - Comunicado de la FDA sobre la seguridad de los medicamentos: Ritmo cardiaco anormal que puede estar asociado con el uso de Zofran (ondansetrÃn)

(canagliflozin): Drug Safety Communication - Boxed Warning Removed

Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert - Boxed Warning about Risk of Leg and Foot Amputations Removed [Posted 08/26/2020] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: Based on FDA's review of new data from three clinical trials, the boxed warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) was removed from the prescribing information. FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which led to additional approved uses. Specifically, in 2018, canagliflozin was approved to reduce the risk of major heart-related events such as heart attack, stroke, or death in patients with type 2 diabetes who have known heart disease; and, in 2019, it was approved to reduce the risk of end-stage kidney disease, worsening of kidney function, heart-related death, and being hospitalized for heart failure in certain patients with type 2 diabetes and diabetic kidney disease. Collectively, these newly identified effects of canagliflozin on heart and kidney disease show significantly enhanced benefit of this medicine. Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based upon these considerations, FDA has concluded that the boxed warning should be removed. BACKGROUND: Today's information is an update to the FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) issued on May 16, 2017. Canagliflozin belongs to a class of medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. RECOMMENDATION: Health care professionals and patients should continue to recognize the importance of preventative foot care and monitor for new pain, tenderness, sores, ulcers, and infections in the legs and feet. Risk factors that may predispose patients to the need for amputation should be considered when choosing antidiabetic medicines. Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178. [08/26/2020 - Drug Safety Communication - FDA] [05/16/2017 - Drug Safety Communication - FDA]

FDA removes Boxed Warning for type 2 diabetes medicine canagliflozin

FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) Based on our review of new clinical trial data Drug Safety Communication (PDF - 58KB) 8-26-2020 FDA Drug Safety Communication Based on a U.S. Food and Drug Administration (FDA) review of new data from three clinical trials, we have removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information. We required the Boxed Warning in 2017 based on our assessment that the risk of amputations was very serious in relation to the potential benefit of canagliflozin, which was initially approved to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Subsequent FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which led to additional approved uses. Specifically, in 2018, canagliflozin was approved to reduce the risk of major heart-related events such as heart attack, stroke, or death in patients with type 2 diabetes who have known heart disease; and, in 2019, it was approved to reduce the risk of end-stage kidney disease, worsening of kidney function, heart-related death, and being hospitalized for heart failure in certain patients with type 2 diabetes and diabetic kidney disease. Collectively, these newly identified effects of canagliflozin on heart and kidney disease show significantly enhanced benefit of this medicine. Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based upon these considerations, we have concluded that the Boxed Warning should be removed. The amputation risk with canagliflozin remains and is still described in the Warnings and Precautions section of the prescribing information. Health care professionals and patients should continue to recognize the importance of preventative foot care and monitor for new pain, tenderness, sores, ulcers, and infections in the legs and feet. Risk factors that may predispose patients to the need for amputation should be considered when choosing antidiabetic medicines. Canagliflozin belongs to a class of medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. We urge health care professionals and patients to report side effects involving canagliflozin and other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page. Related Information - Drug Safety Podcast - Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors - National Institute of Diabetes and Digestive and Kidney Diseases: Diabetes - The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective - Think It Through: Managing the Benefits and Risks of Medicines Contact FDA For More Info 855-543-DRUG (3784) and press 4 druginfo@fda.hhs.gov Report a Serious Problem to MedWatch Complete and submit the report Online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Physicochemical and Structural (Q3) Characterization of Topical Drug

GUIDANCE DOCUMENT Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs March 2026 - Docket Number: - FDA-2022-D-1864 - Issued by: - Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of Regulatory Policy The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.” This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes (referred to as “topical products”). This guidance provides recommendations for physicochemical and structural (collectively, “Q3”) characterizations that can be used to identify the dosage form of a proposed generic (test) topical product, and to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE)). This guidance finalizes the draft guidance of the same title issued on October 21, 2022. Submit Comments You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's docket number: FDA-2022-D-1864.

Pioglitazone (marketed as Actos, Actoplus Met, Duetact, and Oseni) Inf

Pioglitazone (marketed as Actos, Actoplus Met, Duetact, and Oseni) Information Pioglitazone is sold as a single-ingredient product under the brand-name Actos and is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). It is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page. Related Information - FDA Drug Safety Communication: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer - FDA Drug Safety Podcast for Healthcare Professionals: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure - FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure - FDA reviewing preliminary safety information on Actos (pioglitazone) - Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer - Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact) - Healthcare Professional Sheet text version - Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk

FDA’s Actions to Address Unapproved Thyroid Medications

FDA’s Actions to Address Unapproved Thyroid Medications Medications for treatment of hypothyroidism Hypothyroidism is a condition of decreased thyroid hormone production from the thyroid gland, which affects about 2% of the adult population in the United States. Millions of Americans take thyroid hormone replacement medications to treat hypothyroidism. This medication works to replace the hormones patients need to maintain normal thyroid hormone levels and helps prevent or lessen symptoms of hypothyroidism, such as fatigue, weight gain, constipation, cold intolerance or depressed mood, among others. Generally, thyroid hormone replacement medications need to be dosed very carefully. A dose that is too high or low may not produce the intended effect, may increase the symptoms of hypothyroidism or may cause side effects. This means a doctor needs to monitor a patient’s thyroid hormone levels closely and adjust their medication dose precisely to keep their levels in the right range. Currently there are two types of thyroid hormone replacement medicines on the market, available only by prescription: - The most commonly used type of therapy is synthetic (laboratory-made) medications containing levothyroxine or liothyronine. An estimated 22 million patients received prescriptions for levothyroxine dispensed by U.S. outpatient retail and mail-order pharmacies in 2024. These medications have been FDA-approved for decades and are marketed as branded and generic medications containing levothyroxine sodium or liothyronine sodium. Search drugs@fda for a list of FDA-approved medications. - The second type of therapy is animal-derived thyroid medication and sometimes called desiccated thyroid extract, or DTE. These medications are marketed as Armour Thyroid, NP Thyroid, Nature-Thyroid and Natural Thyroid, among other names. These medications are produced from dried, ground animal thyroid glands (usually porcine, meaning from a pig). Animal-derived thyroid medications are not FDA approved, yet an estimated 1.5 million patients received prescriptions for these medications from U.S. outpatient retail and mail-order pharmacies in 2024. Due to their complex biological origin, these medications contain many compounds that are uncharacterized for safety and effectiveness. Professional medical society guidelines recommend synthetic levothyroxine as the preferred treatment for hypothyroidism, with the goal of normalizing thyroid hormone levels. FDA plans to issue draft guidance FDA is committed to ensuring safety of patients currently using unapproved animal-derived thyroid medications while manufacturers are working toward FDA approval for these medications. On March 11, 2026, FDA informed manufacturers, importers and distributors of marketed unapproved animal-derived thyroid medications of its intent to issue a guidance regarding the agency’s compliance priorities by August 2026. The agency also informed manufacturers of its intent to issue a guidance in 2026 regarding the development of these products to support the submission of marketing applications. FDA is currently applying its risk-based enforcement approach to unapproved animal-derived medications, and may take action. For example, the agency may take action against a manufacturer that is not meeting quality standards and putting patients at risk. Additionally, these unapproved animal-derived thyroid medications are not eligible for compounding because these products are regulated as biological products under the Public Health Service Act. FDA’s concerns with unapproved thyroid medications FDA has concerns with the safety and effectiveness of unapproved animal-derived thyroid medications, because they have not been reviewed by FDA to ensure the safety, purity and potency. These medications may have quality and dosing issues. For example: - Tablets made from the same manufacturing batches of animal-derived source material may not always provide the same thyroid hormone levels. Inconsistent doses of thyroid level hormones can have serious consequences for patients. Too much medication can cause unwanted effects, and too little may not be effective. - Unapproved thyroid medications have an increased risk of certain impurities due to the source – animal thyroid glands – or the way it is manufactured. These issues can lead to infections and other health concerns. The agency has received complaints from patients and reports of adverse events related to the safety and potency of these unapproved medications. FDA recommendations for patients FDA is committed to ensuring safety of patients currently using unapproved animal-derived thyroid medications while manufacturers are working toward FDA approval for these medications. The agency continues to recommend patients taking unapproved animal-derived thyroid medications to treat hypothyroidism talk to their doctor. Your primary care doctor or a professional medical society, such as the Endocrine Society or the American Association of Clinical Endocrinologists, can help identify an experienced endocrinologist, which is a specialist who supports patients with thyroid and other hormone disorders. The Endocrine Society, American Thyroid Association (ATA) and American Association of Clinical Endocrinologists (AACE) provide information about hypothyroidism and its treatment on their websites for patients and health care providers.

FDA Review of BLAs for Blood and Source Plasma

Virtual | Virtual Event Title Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma May 12, 2026 - Date: - May 12, 2026 - Time: - 9:00 a.m. - 2:00 p.m. ET - Organized By: Attend The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Blood Research and Review (OBRR) is hosting a public webinar on Tuesday, May 12, 2026, from 9:00 AM - 2:00 PM ET. PURPOSE OF THE WEBINAR: This webinar is intended to provide blood establishments and other stakeholders with an overview of OBRR’s approach to the review of biologics license applications for the manufacture of blood and blood components, including Source Plasma. In this event, OBRR staff will give presentations on select topics and address questions submitted by registrants. OBJECTIVES: - Explain the process for submission and review of biologics license applications for blood and blood components, including Source Plasma - Describe FDA regulatory requirements for the manufacture of blood and blood components - Describe OBRR’s pre-license and pre-approval inspection process and common citations. - Address commonly asked questions from blood establishments and other stakeholders. BACKGROUND: In 2021, blood establishments in the United States collected approximately 15 million blood components for 14.5 million transfusions. In addition, Source Plasma establishments collected approximately 43 million units of Source Plasma in 2021. OBRR regulates the collection of blood and blood components used for transfusion or for the manufacture of plasma derived products to ensure the safety of the blood supply and to protect the health of blood donors. This webinar will discuss topics relevant to the manufacture of blood and blood components including Source Plasma and address questions submitted by participants ahead of the meeting. Meeting Logistics and Registration: This meeting is free and open to the public; however, registration is required. Early registration is recommended. - Date: May 12, 2026 - Time: 9:00 a.m. – 2:00 p.m. ET - Location: This webinar will be held via Microsoft Teams. - Registration: To register for the webinar, please visit the following link: https://events.gcc.teams.microsoft.com/event/OBRRWebinar2026 Registration will close on Friday, April 10, 2026, at 11:59 p.m. ET. A recording and other relevant meeting materials will be posted online following the event. - Submit a Question: Registrants should submit any questions for speakers to CBERPublicEvents@fda.hhs.gov by Friday, April 10, 2026. Please include “OBRR Webinar 2026” in the subject line. Please note, FDA is not able to comment on or answer questions regarding specific investigational new drug submissions, or biologics license applications, or draft guidance documents during the webinar. Further, questions considered out of scope for the event will not be addressed. Stay Connected Sign up for the CBER listserv or

Workshops, Meetings & Conferences (Biologics)

Workshops, Meetings & Conferences (Biologics) FDA's Center for Biologics Evaluation and Research (CBER) sponsors or co-sponsors meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties. Minutes, transcripts, summaries and/or presentations for CBER sponsored or co-sponsored meetings and workshops are made available as soon after the meeting as possible. Presentations are in chronological order, with the most recent event at the top of the list. Most will be removed after one year. If you want to keep the slides for future reference, they may be downloaded and saved. Slides that have been removed from the web site may be requested by submitting a written request to FDA's Freedom of Information staff. View FDA Archive for past meetings and materials: 2011-2015; 2016-2020. Upcoming Workshops, Meetings, & Conferences - FDA CBER OTP Public Listening Meeting: Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies September 18, 2025 - FDA Public Meeting: Onshoring Manufacturing of Drugs and Biological Products September 30, 2025 - OTP Town Hall: Gene Therapy Manufacturing CMC and Facility Readiness for BLAs and Post-licensure Changes October 22, 2025 - Approval of New Patch Tests for the Diagnosis of Allergic Contact Dermatitis; Public Workshop October 23, 2025 - Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants October 25, 2024 - 2024 Center for Biologics Evaluation and Research (CBER) Science Symposium September 16 - 18, 2024 - Biomarker-driven Drug Development for Allergic Diseases and Asthma; Public Workshop February 22, 2024 - WCBP Symposium 2024 January 23 - 25, 2024 - Workshop for the Identification and Standardization of Methods for Assessing Gene Therapy Product Activity and Comparability and the Evaluation of T-Cell Therapies November 16, 2023 - November 17, 2023 - Warrior Families: Advancing Regenerative Medicine Through Science October 5, 2023 - OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products August 30, 2023 - OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023 June 8, 2023 - RDEA Pilot Program 2023 Public Workshop June 7 - 8, 2023 - Regulatory Education for Industry (REdI) Annual Conference 2023 June 5 - 9, 2023 - Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products April 27, 2023 - Recombinant Protein-Based COVID-19 Vaccines Workshop April 27, 2023 - OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023 April 25, 2023 - Clinical Trials: The Patient Experience APRIL 13, 2023 - Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards April 4, 2023 - November 7, 2023 - Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop March 30, 2023 - FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop March 14, 2023 - OTAT Town Hall: Clinical Development of Gene Therapy Products for Rare Diseases February 7, 2023 - Assessing Genetic Heterogeneity in the Context of Genome Editing Off-Targets in Gene Therapy Products December 16, 2022 - FDA Clinical Investigator Training Course (CITC) 2022 December 7 - 8, 2022 - OTAT Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls December 7, 2022 - FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement November 14 - 16, 2022 - FDA CBER OTAT Patient-Focused Drug Development Listening Meeting — Patient Perspectives on Gene Therapy Products November 15, 2022 - Natural History Studies to Support Regenerative Medicine: A How-To Webinar October 27, 2022 - FDA NanoDay Symposium 2022 October 11, 2022 - OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls September 29, 2022 - 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium September 20-22, 2022 - Regulatory Education for Industry (REdI) Annual Conference 2022 June 6 - 10, 2022 - Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates May 24, 2022 - RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases March 9, 2022 - Regenerative Medicine 101 Webinar: Information for Patients, Caregivers & Advocates November 16, 2021 - Science and Regulation of Bacteriophage Therapy Workshop August 30 - September 1, 2021 - Regulatory Education for Industry (REdI) Annual Conference 2021 July 19 - 23, 2021 - Model Informed Drug Development Approaches for Immunogenicity Assessments June 9, 2021 - Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates May 6, 2021 Follow CBER Division of Communication and Consumer Affairs Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave WO71-3103 Silver Spring, MD 20993-0002 (800) 835-4709 (240) 402-8010 For Updates on Twitter, follow @fdacber

Pyrogen and Endotoxins Testing: Questions and Answers | FDA

Issued by: Guidance Issuing Office Center for Veterinary Medicine Human Foods Program Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Biologics Evaluation and Research This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> “Bacterial Endotoxins Test”, USP Chapter <161> “Medical Devices ‒ Bacterial Endotoxin and Pyrogen Tests”, and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72). These three documents describe the fundamental principles of the gel clot, photometric, and kinetic test methods, and recommend that appropriate components and finished products be tested for the presence of pyrogens and endotoxins. Submit Comments Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All comments should be identified with the title of the guidance.