Search Medical Journals & Research Articles

Plasminogen, Human-tvmh

The.gov means it’s official. Federal government websites often end in.gov or.mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Pooled Plasma (Human), Solvent/Detergent Treated

The.gov means it’s official. Federal government websites often end in.gov or.mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Prothrombin Complex Concentrate, Human-LANS

The.gov means it’s official. Federal government websites often end in.gov or.mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Adverse Events and Product Deviation Guidances

Should you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA. Providing Submissions in Electronic Format - Postmarketing Safety Reports for Vaccines - Guidance for Industry CBER, August 2015 Draft Guidance for Industry: Providing Submissions in Electronic Format - Postmarketing Safety Reports CDER/CBER, June 2014 Guidance for Industry: E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide - Data Elements and Message Specification (version 5.01) CDER/CBER, February 2014 Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic OCET/CDER/CBER/CFSAN/CDRH, February 2012 Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components; Guidance for Industry CBER/CDER, October 2006 Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products - Content and Format CDER/CBER, January 2006 Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines CDER/CBER, March 2001 Guidance for Industry: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report CDER/CBER, August 1997

Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

AUDIENCE: Patient, Health Care Professional, Pharmacy, Hematology ISSUE: Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic events are such that the FDA considers the risks of the product to outweigh its benefits. The FDA has communicated this position to AstraZeneca, and the company has submitted a request to voluntarily withdraw the BLA for the product for commercial reasons. Additionally, the company has confirmed that it will end U.S. commercial sales today, December 22, 2025. Andexxa will no longer be manufactured for or sold in the U.S. by AstraZeneca after December 22, 2025. Continuous monitoring and assessment of the safety of all biological products, including Andexxa, is an FDA priority, and we remain committed to informing the public when we learn new information about these products. BACKGROUND: The FDA initially granted accelerated approval (AA) of Andexxa, a recombinant modified human factor Xa (FXa) protein, in 2018, indicated for patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Initial approval included a Boxed Warning for thromboembolic risks. AA was granted based on the change from baseline in anti-activated FXa (anti-FXa) activity in healthy volunteers, as a surrogate endpoint reasonably likely to predict clinical benefit. At the time of AA of Andexxa, AstraZeneca (Applicant) was subject to a requirement to conduct a randomized controlled trial (NCT03661528) to verify the clinical benefit of Andexxa among patients with intracerebral hemorrhage following treatment with rivaroxaban or apixaban. On January 31, 2024, the Applicant submitted a supplemental Biologics Licensing Application (sBLA) for Andexxa with the results of the ANNEXA-I trial to fulfill this requirement. The FDA convened a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (AC) on November 21, 20241, to discuss the results of the ANNEXA-I trial. The major safety findings discussed at the AC meeting included a doubling of the rate of thromboses and thrombosis-related deaths at Day 30 in the Andexxa arm compared with usual care (UC): Increased risk of thrombosis: ANNEXA-I demonstrated an increased incidence of thrombosis (14.6% versus 6.9%) and thrombosis-related deaths at Day 30 (2.5% versus 0.9%) in the Andexxa arm compared with the UC arm, respectively. Death related to thrombotic events through 30 days occurred in 6 patients (2.5%) in the Andexxa arm compared with 2 patients (0.9%) in the usual care control arm. The FDA will continue working with AstraZeneca to keep providers and the public informed as AstraZeneca prepares to end sale of Andexxa. 1Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting Announcement

Coagulation Factors

The.gov means it’s official. Federal government websites often end in.gov or.mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Standards Development for Regenerative Medicine Therapies

Section 3036 of the 21st Century Cures Act refers to the development of standards for regenerative medicine therapies, including products designated Regenerative Medicine Advanced Therapies (RMATs). In consultation with the National Institute of Standards and Technology (NIST) and stakeholders, FDA is facilitating efforts to coordinate the development of standards for regenerative medicine therapies. Beginning in 2017, FDA has awarded an annual contract to Nexight Group and the Standards Coordinating Body (SCB) to coordinate community efforts toward the development of standards for regenerative medicine therapies. Under these contracts, Nexight has conducted public workshops and webinars to develop processes to enable identification of needed standards and facilitated the development of standards that have a high impact on the quality and safety of regenerative medicine therapies. In addition, SCB maintains the Regenerative Medicine Standards Portal (an interactive database that displays standards applicable to regenerative medicine therapies and the status of these standards (identified as needed, under development, or available). In October 2023, FDA published “Guidance for Industry: Voluntary Consensus Standards Recognitions Program for Regenerative Medicine Therapies”. This guidance describes a standards recognition program (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify and recognize Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. CBER encourages the use of appropriate standards in the development of CBER-regulated products. The use of recognized VCS can assist stakeholders in meeting regulatory requirements more efficiently and increasing regulatory predictability for RMT products. CBER is posting a list of recognized standards on this page as stated in the guidance. CBER Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies Last updated on December 13, 2024

ABRYSVO

STN: 125769; 125768 Proper Name: Respiratory Syncytial Virus Vaccine Tradename: ABRYSVO Manufacturer: Pfizer Inc. Indication: ABRYSVO is indicated for: Active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. Active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older. Active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Product Information Package Insert - ABRYSVO Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (ABRYSVO) Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable. Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (ABRYSVO) (STN 125768) Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable. Latest Safety Information FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy January 7, 2025 Supporting Documents December 19, 2025 Approval Letter - ABRYSVO July 30, 2025 Approval Letter - ABRYSVO (125769/427) June 9, 2025 Approval Letter - ABRYSVO (125769/277) January 6, 2025 Approval Letter - ABRYSVO (125769/388) October 22, 2024 Approval Letter - ABRYSVO (STN125769/225) August 30, 2024 Approval Letter - ABRYSVO (STN 125769/3) July 29, 2024 Approval Letter - ABRYSVO (STN 125769/203) March 14, 2024 Approval Letter - ABRYSVO (STN 125769/117) September 12, 2023 Summary Basis for Regulatory Action - ABRYSVO (STN 125768) August 21, 2023 Approval Letter - ABRYSVO (STN 125769/26) August 21, 2023 Approval Letter - ABRYSVO (STN 125768) May 31, 2023 Approval Letter - ABRYSVO May 31, 2023 Summary Basis for Regulatory Action - ABRYSVO Approval History, Letters, Reviews, and Related Documents - ABRYSVO Approval History, Letters, Reviews, and Related Documents - ABRYSVO (STN 125768)

Antihemophilic Factor (Recombinant)

The.gov means it’s official. Federal government websites often end in.gov or.mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

BK251265 - Ortho Elution Kit

The.gov means it’s official. Federal government websites often end in.gov or.mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Cleared 510(k) Submissions with Supporting Documents - 2025 | FDA

This list includes cleared 510(k) submissions for 2025 for which we have supporting documents available and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.The clearances are listed by clearance date in reverse chronological order.510(k) NumberApplicantDevice NameDecision DateBK251248Bahia MedicalPlano, TX 75024PRiSM PRP12/23/2025BK251197HsingChi Medical Ltd.TAIWAN“HsingChi” LipoSelector Disposable Fat Collection System (LS-1200)12/23/2025BK251285Roche DiagnosticsIndianapolis, IN 46250Elecsys Syphilis12/10/2025BK251286Roche Molecular Systems, IncPleasanton, CA 94588a) cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systemsb) cobas® HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas® 5800/6800/8800 systems11/21/2025BK251268Synova Life Sciences, Inc.Los Angeles, CA 90032Synova Wave Adipose Processing System11/17/2025BK251272Alba Bioscience LimitedUnited KingdomAlba Elution Kit11/14/2025BK251265Alba Bioscience LimitedUnited KingdomORTHO® Elution Kit11/12/2025BK251174MimiX Biotherapeutics, LtdFastSkin Patch11/07/2025BK251238Ortho-Clinical Diagnostics, Inc.ORTHO VISION® Analyzer and ORTHO VISION® Max Analyzer10/10/2025BK251256Immucor, Inc.Norcross, Georgia 30071ImmuLINK (v3.3)10/24/2025BK251237Micro Typing Systems, Inc.DAT Control (MTSTM DAT Card)10/10/2025BK251280Roche DiagnosticsIndianapolis, IN 46250cobas pro serology solution (applicable to) Elecsys Syphilis and Elecsys Anti-CMV10/09/2025BK251201Rmedical Co., LtdDR.PRP-3010/08/2025BK251157B.T.I. Biotechnology Institute, S.L.Miñano (Álava), SpainENDORET® Kit10/03/2025BK251241Haemonetics CorporationBoston, MA 02110SafeTrace Tx® Software 5.0.009/10/2025BK251196StemC Biyoteknoloji Anonim SirketiNew Smyrna Beach, FL 32168Exocube Set08/28/2025BK251234Abbott MolecularDes Plaines, IL 60018Alinity m HIV-1 AMP KitAlinity m HIV-1 CTRL KitAlinity m HIV-1 CAL KitAlinity m HIV-1 Application Specification File08/27/2025BK251254Bio-Rad Laboratories, IncWoodinville, WA 98072Geenius™ HIV 1/2 Supplemental Assay08/26/2025BK251199EUROMI S.ABelgiumNLF system® kit 2 (EUROMI)08/14/2025BK251235Roche Molecular Systems, Inc Pleasanton, CA 94588cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems07/01/2025BK251233Roche Molecular Systems, Inc Pleasanton, CA 94588cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems06/27/2025BK251184Diagnostic Grifols, S.A.Barcelona, SpainDG Gel 8 Neutral card06/17/2025BK251183Diagnostic Grifols, S.A.Barcelona, SpainErytra06/17/2025BK251182Diagnostic Grifols, S.A.Barcelona, SpainErytra Eflexis06/17/2025BK251188MAK-SYSTEM Group Ltd.London United KingdomPatient Health Software (P.H.S) v11.0.0.006/11/2025BK241116DiaSorin, Inc.Stillwater, MNLIAISON® MUREX HIV Ab-Ag HT and LIAISON® MUREX Control HIV Ab-Ag HT06/10/2025BK241079Innoveren Scientific, Inc.Cincinnati, OHPeripheral blood processing device for wound management03/28/2025BK231039Delcon S.r.l.ItalyGiotto Monza (BCS03)03/26/2025BK251160Fresenius Kabi AGLake Zurich, ILAdaptive Nomogram Bottle02/21/2025BK241136BioLife Plasma Services LPBannockburn, ILLookback Notification System version 2.002/20/2025BK241135Fresenius Kabi AG Lake Zurich, ILAurora Xi Plasmapheresis System Software Version 2.001/24/2025BK231018Sunphoria Co.,LtdTaiwanAHC Platelet Concentrate Separator01/10/2025BK241148Roche DiagnosticsIndianapolis, INcobas pro serology solution (applicable to)a) Elecsys Syphilis andb) Elecsys Anti-CMV01/10/2025BK210601Immucor, Inc.Norcross, GAEcho Lumena01/08/2025BK210604Immucor, Inc.Norcross, GAComplement Control Cells01/08/2025BK210608Immucor, Inc.Norcross, GAGalileo Echo01/08/2025BK241067Immucor GTI Diagnostics, Inc. Waukesha, WIMatchX01/02/2025

HIBERIX

STN: 125347 Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Tradename: HIBERIX Manufacturer: GlaxoSmithKline Biologicals S.A. Indication: HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday). Product Information Package Insert - HIBERIX Supporting Documents December 17, 2025 Approval Letter - HIBERIX December 20, 2023 Approval Letter - HIBERIX April 30, 2018 Approval Letter - Hiberix To include safety and effectiveness data. April 27, 2018 Summary Basis for Regulatory Action - Hiberix January 14, 2016 Clinical Review - HIBERIX January 14, 2016 Statistical Review - HIBERIX Approval History, Letters, Reviews, and Related Documents - Hiberix Supporting Documents older than three years - Hiberix

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FDA

Docket Number: FDA-2023-D-4395 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research Download the Current Final Guidance Download the Revised Final Guidance FDA recognizes and anticipates that the Agency and industry may need up to 60 days to perform activities to operationalize the recommendations within this guidance. For regulatory submissions that are currently pending with FDA after publication of the guidance, as well as those submissions received within 60 days following publication of the guidance, FDA generally does not anticipate that sponsors will be ready to include the newly recommended information outlined in the guidance in their submission. FDA, however, intends to review any such information if submitted at any time. FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This guidance includes expanded and updated recommendations to FDA staff and sponsors considering using RWE to support a regulatory submission for medical devices. This document supersedes the final guidance of the same name, issued August 31, 2017. Submit Comments Submit Comments Online 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-2023-D-4395.

Procleix Babesia Assay

STN# 125673 Proper Name: Procleix Babesia Assay Tradename: Procleix Babesia Assay Manufacturer: Grifols Diagnostics Solutions Inc. Indication: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens. It is intended for use in screening individual human donors, including donors of whole blood and blood components, and in screening living donors of organ and tissue. It is also intended for use in screening cadaveric (non-heart-beating) donors for B. microti. It is not intended for use on cord blood specimens. Lysed individual donor whole blood samples are tested either individually or in pools of equal aliquots of not more than 16. Cadaveric donor specimens must be tested individually and not pooled. This assay is not intended for use as an aid in diagnosis of Babesia infection. Product Information Package Insert - Procleix Babesia Assay Supporting Documents December 16, 2025 Approval Letter - Procleix Babesia Assay November 20, 2020 Approval Letter - Procleix Babesia Assay February 12, 2020 Approval Letter - Procleix Babesia Assay January 24, 2019 Approval Letter – Procleix Babesia Assay January 18, 2019 Summary Basis of Regulatory Action - Procleix Babesia Assay

Fractionated Plasma Products

The following products are regulated as Fractionated Plasma Products: Fractionated Plasma Products With Supporting Documents Albumin Alpha-1 Proteinase Inhibitor Antihemophilic Factor (Recombinant) Antihemophilic Factor (Recombinant), Glycopegylated-Exei Antihemophilic Factor (Recombinant), Pegylated-Aucl Antihemophilic Factor/von Willebrand Factor Complex Anti-Inhibitor Coagulant Complex Antithrombin (Recombinant) Antithrombin III (Human) C1 Esterase Inhibitor Coagulation Factors Coagulation Factor VIIa (Recombinant) - JNCW Coagulation Factor XA (Recombinant), Inactivated-ZHZO Corifact Fibrin Fibrinogen Immune Globulins Immune Globulin Subcutaneous, Human-DIRA Immune Globulin Subcutaneous, Human-KTHM, 10% Solution Immune Globulin Subcutaneous, Human-STWK Immune Globulin Subcutaneous (Human) Plasminogen, Human-TVMH Pooled Plasma (Human), Solvent/Detergent Treated Profilnine SD - Factor IX Complex Prothrombin Complex Concentrate, Human-LANS Kcentra (Prothrombin Complex Concentrate, Human) Protein C Concentrate Thrombin von Willebrand Factor (Recombinant)