FDA Invites Drug Makers to Quality Maturity Challenge
Published Date: 4/23/2025
Notice
Summary
The FDA is inviting a select group of drug makers to join a fun, voluntary program that checks how well they manage quality in their factories. This second-year program helps improve the way quality is measured, making sure medicines are safe and reliable. Interested companies have until June 9, 2025, to apply—no fees, just a chance to shine and help shape the future of drug quality!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Voluntary QMM program — apply by June 9, 2025
If your drug manufacturing establishment wants to volunteer for FDA's Quality Management Maturity (QMM) assessment, you must submit a request to participate by June 9, 2025. CDER intends to select up to nine volunteer participants, and plans to notify each applicant of its decision within 45 days after the close of the request period.
Who may participate — eligibility rules
To be eligible, an establishment must register under section 510 of the FD&C Act (as defined in 21 CFR 207.1), have received at least one human drug surveillance inspection (FDA or Mutual Recognition Agreement partner inspections count), have a current inspection classification of No Action Indicated or Voluntary Action Indicated, and manufacture at least one CDER-regulated drug (API or finished product) that is commercially distributed in the United States. Establishments must also be willing to participate in an onsite or hybrid assessment.
Assessment format, report, and improvement follow-up
Selected establishments will receive a 5-day QMM assessment conducted by teams of three CDER assessors (not including personnel from FDA's Office of Inspections and Investigations). After the assessment you will get a report with a score, narrative, strengths, and opportunities for each practice area. About 3 months after the report you will share an improvement plan with CDER and meet to discuss it, and about 6 months after the report CDER will schedule a final meeting to discuss progress.
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.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20727, Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
The FDA is officially classifying home test kits that detect non-viral germs causing sexually transmitted infections as Class II devices, meaning they have special safety rules but fewer hurdles than the strictest category. This change, effective October 9, 2026, helps make these tests safer and easier to get, benefiting patients and innovators alike. If you make or use these home test kits, this update means better access and clear safety standards without extra costs or delays.
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 is inviting everyone to share their thoughts on using a new tech standard called HL7 FHIR to submit real-world health data for drug and biologic studies. This change aims to make data submissions easier, clearer, and more organized for companies, health tech vendors, and researchers. Comments are open until June 23, 2025, so don’t miss your chance to help shape the future of health data sharing!
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 (aflibercept) by approving it using a special priority review voucher designed for urgent medical threats. This means the drug got a faster review because it helps with serious health risks, speeding up access for patients and healthcare providers. The approval was official as of April 18, 2023, and this move highlights the FDA’s commitment to quick action on important medicines.