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What are the Qualifications and Requirements of RDRC Membership?

Reference: 21 CFR 361.1(c)(1) A Radioactive Drug Research Committee (RDRC) must consist of at least five individuals A physician recognized as a specialist in nuclear medicine [§ 361.1(c)(1)]. A person qualified by training and experience to formulate radioactive drugs [§ 361.1(c)(1)]. A person with special competence in radiation safety and radiation dosimetry [§ 361.1(c)(1)]. Individuals qualified in various disciplines pertinent to the field of nuclear medicine (e.g., radiology, internal medicine, clinical pathology, hematology, endocrinology, radiation therapy, radiation physics, radiation biophysics, and radiopharmacy) [§ 361.1(c)(1)]. Other considerations Membership must be sufficiently diverse to permit expert review of technical and scientific aspects of protocols [§ 361.1(c)(1)]. FDA encourages the addition of consultants in pertinent medical disciplines depending on expertise needed to oversee specific studies (e.g., pediatric specialist) [§ 361.1(c)(1)]. Radioactive Drug Research Committee (RDRC) Program

Radioactive Drug Research Committee (RDRC) Program

What is the RDRC program? What are the qualifications and requirements of RDRC membership? How does an RDRC obtain FDA approval? What are the responsibilities of the RDRC? What information does the RDRC review? Federal Regulations (21 CFR 361.1) RDRC forms and checklist RDRC CDER NextGen Portal for Electronic Submissions Guidances for industry FDA RDRC presentations List of active RDRC sites Contact us What is the RDRC Program? The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July 25, 1975 classifying all radioactive drugs as either new drugs requiring an Investigational New Drug Application (IND) for investigational use (21 CFR 312) or as generally recognized as safe and effective when administered under the conditions specified in the RDRC regulations (21 CFR 361.1). The RDRC program under 21 CFR 361.1 permits basic research using radioactive drugs* in humans without an IND when the drug is administered under the following conditions: The research is considered basic science research and is done for the purpose of advancing scientific knowledge. Under § 361.1(a), this type of research is: intended to obtain basic information regarding the metabolism (including kinetics, distribution, dosimetry, and localization) of a radioactive drug or regarding human physiology, pathophysiology, or biochemistry, not intended for immediate therapeutic, diagnostic or similar purposes (e.g. preventive benefit to the study subject from the research), and not intended to determine the safety and effectiveness of a radioactive drug in humans. The research study is approved by an FDA-approved RDRC based on the following requirements [§ 361.1(b)(1)(iv)]: qualified study investigators properly licensed medical facility to possess and handle radioactive materials appropriate selection and consent of research subjects appropriate quality assurance of radioactive drug administered sound research protocol design reporting of adverse events by the investigator to the RDRC approval by an appropriate Institutional Review Board (IRB) The pharmacologic dose of the radioactive drug to be administered is known not to cause any clinically detectable pharmacologic effect in humans [§ 361.1(b)(2)]. The radiation dose to be administered is justified by the quality of the study being undertaken and the importance of the information it seeks to obtain [§ 361.1(b)(1)(iii)] and is within the limits specified in § 361.1(b)(3). *The term “radioactive drug” is defined in 21 CFR 310.3(n) and includes a “radioactive biological product” as defined in 21 CFR 600.3 RDRC Forms and Checklist Search for "RDRC" on FDA Forms page to get FDA 2914: Report on Research use of Radioactive Drugs: Membership Summary FDA 2915: Report on Research use of Radioactive Drugs: Study Summary RDRC Protocol Review Checklist: Criteria for the Evaluation of the Appropriateness of Research Studies Under a RDRC (PDF - 18KB) RDRC CDER NextGen Portal for Electronic Submissions CDER NextGen Portal For Radioactive Drug Research Committee Electronic Submissions Guidances for Industry RDRC Final Guidance: Human Research without an Investigational New Drug Application (August, 2010) (PDF - 417KB) Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments (PDF - 471KB) Part 2: Clinical Indications (PDF - 231KB) Part 3: Design, Analysis, and Interpretation of Clinical Studies (PDF - 307KB) PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399KB) FDA Radioactive Drug Research Committee Program Presentations Presentations from 2016 and older are available on the FDA archive Contact Us You may email the RDRC Team at RDRC@cder.fda.gov. Other Resources Academy of Molecular Imaging American Association of Physicists in Medicine American College of Radiology American Pharmacists Association Conference of Radiation Control Program Directors Health Physics Society International Commission on Radiological Protection Medical Imaging and Drug Development Positron Emission Tomography (PET) Radiological Society of North America Society of Nuclear Medicine

FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma

On December 3, 2025, the Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Full prescribing information for Jaypirca will be posted here. Efficacy and Safety Efficacy was evaluated in BRUIN-CLL-321 (NCT 04666038), a randomized, open-label, active-controlled trial. The trial randomized 238 patients who were previously treated for CLL/SLL, including a covalent BTK inhibitor. Patients previously treated with a non-covalent BTK inhibitor were not permitted. Patients were randomized (1:1) to receive either pirtobrutinib or investigator’s choice of idelalisib plus a rituximab product (IR) or bendamustine plus a rituximab product (BR). Crossover to JAYPIRCA monotherapy was permitted for patients in the investigator’s choice arm after confirmed disease progression. The primary efficacy outcome measure was progression-free survival (PFS), as assessed by an independent review committee using 2018 iwCLL criteria. Median PFS was 11.2 months (95% CI: 9.5, 11.4) in the pirtobrutinib arm and 8.7 months (95% CI: 7.2, 10.2) in the investigator’s choice of IR/BR arm (Hazard ratio 0.58 [95% CI: 0.38, 0.89]; p-value 0.0105). Of the 119 patients in the investigator’s choice arm, 50 crossed over to receive JAYPIRCA therapy. At an updated analysis with a median follow-up time of 19.8 months, the HR for overall survival (OS) was 1.09 (95% CI: 0.68, 1.75). The prescribing information includes warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrythmias, secondary primary malignancies, hepatotoxicity, and embryo-fetal toxicity. Recommended Dosage The recommended pirtobrutinib dose is 200 mg orally once daily until disease progression or unacceptable toxicity. Expedited Programs This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. Pirtobrutinib received orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

eCopy Program for Medical Device Submissions

This is an updated version of the guidance that was issued on April 27, 2020. It provides clarifications to the eCopy Program related to its intersection with the eSTAR Program and the availability of the CDRH Portal, as well as minor updates to reflect modern technical standards (e.g., larger acceptable file size). This guidance provides information on the eCopy Program for medical device submissions. Section 745A(b)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA), requires that Pre-Submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act or section 351 of the Public Health Service Act, and any supplements to such Pre-Submissions or submissions, including appeals of those submissions, be submitted in solely in electronic format, beginning on such date as specified by the Food and Drug Administration (FDA) in final guidance. The eSTAR Program is the current program for submissions solely in electronic format. Until such time that eSTAR is implemented for each specified submission type, Section 745A(b)(1) identifies that Pre-Submissions or submissions for the submission types identified above must be submitted as electronic copies (eCopies). This guidance describes how FDA is implementing the eCopy Program under section 745A(b) of the FD&C Act.

CBER-Regulated Products: Shortages and Discontinuations

CBER's Office of Compliance and Biologics Quality (OCBQ) directs the CBER-regulated product shortage program, which includes product discontinuations. The Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) made substantial changes to section 506C of the FD&C Act related to reporting and addressing interruptions in manufacturing or permanent discontinuances of certain drug products. For example, FDASIA requires manufacturers of certain drug products to notify FDA at least 6 months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. FDASIA excludes radiopharmaceutical products. More information on FDASIA is provided on FDA’s FDASIA Fact Sheet Page. Shortages of drugs and biologics pose a significant public health threat, delaying, and in some cases even denying, critically needed care for patients. Preventing shortages remains a top priority for FDA. For more information please see FDA Facts: Drug Shortages in the United States. Additional information regarding possible causes of CBER-regulated product shortages is provided on the CBER-Regulated Products: Possible Causes of Shortages page. Related Information

Health Fraud Scams

Health Fraud Scams Report Unlawful Sales of Medical Products on the InternetReporte de ventas ilegales de productos medicos a traves del internet Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment. They can also cause serious or even fatal injuries. - Hyaluronic Acid Products Containing Undeclared Ingredients - FDA Advises Consumers, Retailers, and Distributors Not to Eat, Sell, or Distribute Addall XR Shot or Addall XL Dietary Supplements (April 2026) - Chocolates Marketed as Sexual Enhancement Products May be Harmful Due to Undisclosed Drug Ingredients - Tainted Honey-based Products with Hidden Active Drug Ingredients. - FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers News FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers July 29, 2025 - FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers Letter from Dr. Makary to health care professionals: New "Gas Station Heroin" T… May 8, 2025 - Letter from Dr. Makary to health care professionals to draw attention to the increasing number of adverse events involving products containing tianeptine. Letter to Industry on the Use of Amanita Muscaria or its Constituents in Food December 2024 - Letter to Industry on the Use of Amanita Muscaria or its Constituents in Food FDA warns consumers to not purchase or use unapproved inhalant products markete… August 6, 2024 - FDA is warning consumers to not purchase or use certain inhalants, which primarily contain ammonia. FDA Warns Consumers Not to Use Optimized Plant Mediated Solutions (OPMS) Black… July 26, 2024 - The FDA is advising consumers not to consume OPMS Black Liquid Kratom, which has been linked to serious adverse health effects. Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gumm… June 2024 - All Diamond Shruumz-brand products have been recalled and should no longer be available for sale. FDA Issues Warning About Certain Supplements Substituted with Toxic Yellow Olea… December 2024 - FDA analysis has determined that certain products labeled as tejocote (Crataegus mexicana) root or Brazil seed are adulterated because they were tested and found to be substituted with yellow oleander (Thevetia peruviana). Skin Facts! What You Need to Know About Skin Lightening Products March 2024 - The FDA’s Skin Facts! Initiative alerts consumers of potentially harmful over-the-counter (OTC) skin products containing hydroquinone or mercury. Spotlight Health Fraud Product Database This database includes unapproved products that have been subject to FDA health fraud related violations. Umary and Related Products FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your health. These products are promoted to treat pain and other conditions. Cosmetic Products Containing Methylene Chloride FDA has found several cosmetic products marketed as gel nail polish remover that contain methylene chloride as an ingredient. Methylene chloride is a prohibited ingredient, which is not allowed in cosmetics at any level (21 CFR 700.19) Hiding in Plain Sight: 7-OH Products The time to act is now. We can and must prevent the next wave of the opioid crisis. Tianeptine Tianeptine is not approved by the U.S. Food and Drug Administration for any medical use. Despite that, some companies are illegally marketing and selling products containing tianeptine to consumers. Products Containing Cannabis or Cannabis-derived Compounds, Including CBD The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD. How to Spot Health Fraud FDA describes health fraud as "articles of unproven effectiveness that are promoted to improve health, well being or appearance." 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams A health product is fraudulent if it is promoted to treat a disease or condition, but not scientifically proven safe and effective for that purpose. Advisories and Alerts Advisory Letters The U.S. FDA issued letters to these companies for illegally marketing products for the treatment or prevention of serious diseases. Thirty days after FDA issued these letters, the companies listed have failed to voluntarily cease illegally marketing products for serious diseases. Registrar and Registry Abuse Complaints The U.S. FDA sent abuse complaints to registrars managing websites that offer any unapproved drugs or uncleared devices, or potentially counterfeit, controlled, adulterated or misbranded products to U.S. consumers in violation of U.S. law. Health Fraud Warning Letters Warning letters issued to firms for selling fraudulent products with claims. Health Fraud Recalls The page provides information gathered from press announcements and other public notices about certain recalls of health fraud related products regulated by FDA.

24,000 times more harmful to the climate than CO₂: Measurements reveal SF₆ gas emissions in Germany

Sulfur hexafluoride (SF6) is a chemically stable, colorless, odorless, and non-toxic gas. It is used all over the world, primarily as an insulating and protective gas in electrical switchgear within medium- and high-voltage engineering. In the past, it was also used in Germany as a filling gas for sports shoes and as an insulating gas in soundproof windows until this application was banned in 2006.

Missing transporter protein found: How rice distributes iron to young leaves

Iron (Fe) is an essential micronutrient for the healthy growth of plants, including many staple crops like rice. Its deficiency remains a common agricultural problem that slashes crop yields, as it leads to impaired photosynthesis, respiration, and nitrogen metabolism. Thus, establishing mechanisms to ensure crops can efficiently take up and utilize Fe, especially in alkaline soils, is a high-stakes challenge for global food security.

Simulations reveal how black holes generate intense light from infalling matter

Surprisingly, some of the universe's brightest objects are black holes. As scorching gas and dust flow around and into a black hole, they glow with fierce intensity across the light spectrum. Now, a team of computational astrophysicists has developed the most comprehensive simulations ever made of how black holes create these dazzling light shows.

Climate-sensitive tropical pollinators require region-responsive conservation planning, study argues

Pollinators, including bees, butterflies, and beetles, shape global food production and support vast natural ecosystems. For years, efforts to protect these critical species have leaned on broad global targets and uniform conservation recommendations. However, a new study led by researchers at the Indian Institute of Technology Gandhinagar (IITGN) and Northeastern University, U.S., demonstrates that such generalized approaches may not have the desired impact, and in some regions, could offer imperceptible benefit.

Pinning down spinless glueballs: New look at hidden structure inside subatomic particles

SUNY Poly Professor of Physics Dr. Amir Fariborz recently published a paper in Physical Review D titled "Spinless glueballs in generalized linear sigma model." The work takes on a central challenge in modern physics: understanding how the strongest force in nature shapes the inner structure of matter, and how it may produce an unusual form of matter made entirely from the carriers of that force.

These two galaxies are tying the knot and producing stars

Galaxies like our Milky Way grew through cascading mergers of smaller galaxies that began billions of years ago. The ancient progenitors of galaxies like ours were small galaxies similar to modern-day dwarf galaxies like the Large and Small Magellanic Clouds. Research shows that both dwarf galaxies and ancient galaxies are less massive, have lower metallicity, and have lots of star-forming gas but relatively few stars. Astronomers try to understand ancient galaxies and how they grew to become so massive by studying dwarf galaxies that are interacting with each other and beginning to merge.

Video-call glitches can have serious consequences

A technical glitch during a Zoom call shouldn't be that big a deal, or lead someone to make a judgment about the person on the other end. But in actuality, glitches during face-to-face video calls—even when the glitch does not affect the transmission of information—can shatter the illusion of being across the table from the other person, evoking a creepy or eerie feeling known as "uncanniness."

Coastal regions and climate change: How better risk assessment can help protect infrastructure and livelihoods

Coastal regions, where dense clusters of critical infrastructure are found, are facing the sharpest edge of climate change. The threats include paralyzed transport networks and disrupted supply chains. To stay ahead, we need a clearer picture of these vulnerabilities that lets us anticipate the fallout before it comes. But right now, patchy data, inconsistent approaches, and the absence of a unified framework make it tough to grasp the scale of the risk.

Visual thinking: The strategy that could help you spot misinformation and manipulated images

A fake photo of an explosion near the Pentagon once rattled the stock market. A tearful video of a frightened young "Ukrainian conscript" went viral: until exposed as staged. We may be approaching a "synthetic media tipping point", where AI-generated images and videos are becoming so realistic that traditional markers of authenticity, such as visual flaws, are rapidly disappearing.