FDA's Tongue-Twisting Quality Program: Join If You Dare
Published Date: 4/23/2025
Notice
Summary
The FDA is inviting a select group of drug makers to join the second year of a fun, voluntary program that checks how well they manage quality. This helps improve the way quality is measured and gives useful feedback to participants. If you make FDA-regulated drugs, you can apply to join and help shape the future of drug quality management—no cost to join, but spots are limited!
No Economic Impacts Identified for this Document
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.
2026-17498, Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661
The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, entitled "Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661" (91 FR 31462) (the "May 2026 Notice"), as previously extended by the notice published in the Federal Register on June 26, 2026 (91 FR 38717) (the "June 2026 Notice"), by an additional 41 days. The effective date of the May 2026 Notice, which was previously extended to September 24, 2026, is hereby further extended to November 4, 2026. This further extension is necessary to allow FDA sufficient time to consider issues raised by interested parties.
2026-17380, International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments
The FDA is asking the public to share their thoughts on eight drugs that might get new international rules to control their use and abuse. This affects doctors, patients, and drug makers because it could change how these drugs are used medically or restricted worldwide. Comments are open until September 3, 2026, so jump in and have your say before the deadline!
2026-17401, Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cabazitaxel (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), if all other legal and regulatory requirements are met.
Previous / Next Documents
Previous: 2025-06967, Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created From Real-World Data Sources for Submission to the Food and Drug Administration; Establishment of a Public Docket; Request for Comments
The FDA wants your thoughts on using a new tech called HL7 FHIR to make sharing real-world health data for drug studies easier and clearer. This affects drug companies, health tech makers, and researchers who submit data to the FDA. They’ve opened a public comment period now—so speak up and help shape the future of health data submissions!
Next: 2025-06969, Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept)
The FDA just gave a big thumbs-up to EYLEA HD, a medicine that got a fast-track review thanks to a special priority voucher. This means the company behind EYLEA HD moved quickly through the approval process because their product helps protect against serious health threats. Patients and healthcare providers can expect this medicine to be available sooner, with no extra cost signals mentioned.