FDA Extends Drug Safety Advisory Committee
Published Date: 5/26/2026
Notice
Summary
The FDA is renewing its Drug Safety and Risk Management Advisory Committee for two more years, keeping it active until May 31, 2028. This committee helps the FDA make smart decisions about drug safety and risks, protecting everyone who uses medicines. No new costs or big changes, just a continued commitment to keeping drugs safe and sound.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Opioid Safety Labeling Required
Following a May 5, 2025 advisory meeting, FDA required safety labeling changes to all opioid pain medications and sent letters to applicants giving companies 30 days to submit labeling updates for review. These labeling changes explain clearer risks and dosing warnings to help patients and clinicians make safer decisions.
Clozapine REMS Burden Reduced
As of February 24, 2025, FDA no longer expects prescribers, pharmacies, and patients to participate in the REMS program for clozapine or to report absolute neutrophil count (ANC) blood tests before pharmacies dispense clozapine. FDA continues to recommend that prescribers monitor ANC according to the prescribing information.
iPLEDGE REMS Changes for Isotretinoin
On February 9, 2026, FDA approved significant modifications to the iPLEDGE REMS for isotretinoin; the changes—effective August 8, 2026—include allowing at-home pregnancy tests, removing the 19-day lockout/waiting period, and reducing documentation requirements for patient counseling.
FDA Drug Safety Committee Renewed
The FDA renewed the Drug Safety and Risk Management Advisory Committee for two more years so the committee will remain active through May 31, 2028. You will still have this advisory group reviewing drug safety, risk management, and risk communication for FDA-regulated medicines during that period.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-17215, Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the active section of the "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). These therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. This guidance finalizes the draft guidance of the same title issued in July 2022.
2026-17229, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066
The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 066" (Recognition List Number: 066), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
2026-17222, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry titled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Previous / Next Documents
Previous: 2026-10369, Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Delete the Cabinet Upgrade Fee
NYSE Arca is scrapping the $9,200 cabinet upgrade fee for users who want more power in their dedicated cabinets. This change means traders and firms using these cabinets will save money starting immediately. No more surprise charges for power boosts—just smoother, cheaper access to the Exchange’s tech setup!
Next: 2026-10372, Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
The FDA wants your thoughts on how they collect info about making custom human drugs under special rules (Sections 503A and 503B). This affects pharmacies and drug makers who mix medicines just for patients. You’ve got until July 27, 2026, to share your comments—no cost changes yet, just a chance to help shape the paperwork process!