What We Expect the FDA to do in October and November 2025
In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations and comment periods. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.
By Alexander Gaffney, MS, RAC | Sep 29, 2025 2:40 PM EDT
What we expect to be talking about in October and November
- THE END OF THE FISCAL YEAR: Sept. 30 marks the end of the government’s fiscal year, which has a few major implications for the FDA. First, it is the deadline by which Congress must have provided the FDA with additional budget authority, or else it will enter a shutdown. Second, it is the last day before new annual fees for user fee programs go into effect. Third, it is the date on which one of the FDA’s major user fee programs, the Over-the-counter Monograph Drug User Fee Act, or OMUFA, is set to expire unless Congress reauthorizes it. It is also a key date for user fee-driven program deadlines and other reporting deadlines (see our user fee calendar below).
- A LIKELY GOVERNMENT SHUTDOWN: As of the time we are writing this calendar, it appears all but certain that the government will experience a lapse in appropriations and, therefore, a shutdown. For the FDA, while some of its operations will continue (albeit with staff going unpaid), some operations will cease during a shutdown.
- WAITING ON FDA’S PROPOSED ADVERTISING REGULATION: In September, the FDA announced its plans to soon unveil a major regulatory change that would all but ban the life sciences industry from advertising its products on television. We are expecting the FDA to publish this proposed regulation in October, kicking off a likely period of litigation.
- CNPV PROGRAM LAUNCH: FDA Commissioner MARTIN MAKARY has said he expects to make an announcement about his Commissioner’s National Priority Voucher pilot program “very soon,” and we expect that selected companies for the pilot program will be announced in early October.
- USER FEE NEGOTIATION KICKOFFS: This fall will mark the official kickoff of the user fee reauthorization negotiating process for the next iteration of the Prescription Drug User Fee program, known as PDUFA, and potentially other programs such as MDUFA, GDUFA and BsUFA. Expect industry groups to “go dark” to an extent during the negotiations process – a standard part of the negotiating process wherein the FDA and industry don’t comment on the user fee program negotiations.
- DEREGULATORY PRESSURE BUILDS: The first two months of the Trump administration were marked by significant efforts to eliminate and streamline regulations. June saw the start of several major deadlines associated with the administration’s deregulatory efforts, and we expect that we might see an initial list of regulations in October that the administration plans to eliminate.
- THE BIGGEST STRESS TEST OF THE DRUG SUPPLY CHAIN: Nov. 27 marks perhaps the biggest stress test of the drug supply chain in years. It’s the date the FDA will begin to enforce the “enhanced” provisions of the Drug Supply Chain Security Act on large pharmaceutical dispensers (those with more than 25 employees). This deadline has been extended for two years already, largely based on concerns that dispensers weren’t ready to launch interoperable systems and unit-level traceability. We’ll keep a close eye on both the FDA and industry before and after this deadline.
FDA-related deadlines expected to occur in October and November
This list is composed of specific actions and the dates by which the FDA has said it plans to accomplish them.
| Date | What’s Happening | Explanation | Source |
| Sept. 30 | Calendar | End of government fiscal year. | |
| Oct. 1 | Deadline | New FDA user fee submission rates go into effect | FDA |
| Oct. 1 | Deadline | Compliance date for De Novo Submissions. All De Novo submissions for medical devices are required to use the Electronic Submission Template (eSTAR), an interactive PDF form that guides submitters through the process of preparing a comprehensive medical device submission. | FDA |
| Nov. 21 | Anniversary | FDA “early alert” program turns one year old. | FDA |
| Nov. 27 | Deadline | FDA deadline under the Drug Supply Chain Security Act (DSCSA) for dispensers with more than 25 full-time employees to meet enhanced reporting requirements. | FDA |
Regulations and guidance under OIRA review or awaiting publication as of October
The White House’s Office of Information and Regulatory Affairs is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the president. This is what OIRA is currently reviewing. (Note: If a link no longer works, it is likely because OIRA has since cleared the document.)
| Title | Type | Date Received by OIRA | Status |
| Postapproval Pregnancy Safety Studies; Guidance for Industry | Guidance | 08/21/2025 | Under review |
| Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act | Guidance | 09/02/2025 | Under review |
| Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices | Guidance | 09/09/2025 | Under review |
| Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers | Guidance | 07/21/2025 | Under review |
Notable FDA comment periods closing in October and November
FDA comment periods are typically open for 30-60 days unless they are extended.
Meetings that FDA has planned for October and November
These are FDA-hosted events set to take place over the next two months.
Third-party regulatory meetings being held in October and November
These are notable industry events related to regulation, including those at which FDA speakers are confirmed or likely to speak.
| Date | Group | Event | Notable FDA Speakers |
| Oct. 5-8 | AdvaMed | The MedTech Conference 2025 | Michelle Tarver, Suzanne Schwartz, Scott Colburn, Melissa Torres, Jessica Paulsen, Owen Faris, Daniel Caños |
| Oct. 7 | Clinical Trials Transformation Initiative | Artificial Intelligence in Drug & Biological Product Development | |
| Oct. 7-9 | RAPS | RAPS Convergence 2025 | Numerous. AgencyIQ also in attendance |
| Oct. 9-10 | Pharma Biopharma Outsourcing Association | PBOA Annual Meeting and Conference | |
| Oct. 15-16 | UMaryland / FDA | Modeling and Artificial Intelligence (AI) in Generic Drug Development and Product Lifecycle Management: Regulatory Insights and Future Trends | |
| Oct. 15-16 | FDLI | Advertising and Promotion for Medical Products Conference | Twyla Mosey |
| Oct. 16-17 | DIA | Real-World Evidence Conference | Motiur Rahman, Whitney Steele |
| Oct. 19-21 | NORD | NORD Rare Diseases and Orphan Products Breakthrough Summit | Amy Comstock Rick, Robyn Bent, Annie Saha |
| Oct. 19-22 | Infectious Diseases Society of America | ID Week 2025 | |
| Oct. 25-28 | Cardiovascular Research Foundation | Transcatheter Cardiovascular Therapeutics (TCT) 2025 | |
| Oct. 26-29 | ISPE | 2025 ISPE Annual Meeting & Expo | Emily Thakur |
| Oct. 27-29 | AAM, Biosimilars Council | Generics + Biosimilars Conference | Iilun Murphy, Sarah Yim |
| Oct. 28-29 | Personal Care Products Council | 2025 PCPC Science Symposium & Expo | Numerous |
| Nov. 2-5 | American Public Health Association (APHA) | APHA 2025 | |
| Nov. 4 | Friends of Cancer Research | Friends of Cancer Research Annual Meeting 2025 | |
| Nov. 4-6 | Milken Institute | Future of Health Summit 2025 | |
| Nov. 4-6 | Terrapinn | World Drug Safety Congress Americas 2025 | |
| Nov. 4-7 | The Obesity Society | Obesity Week | |
| Nov. 5 | MDIC | MDIC Real-World Evidence Summit | Michelle Tarver |
| Nov. 5-6 | Society of Clinical Research Associates | FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference | Numerous |
| Nov. 6-7 | Decentralized Trials Research Alliance | DTRA 2025 Annual Meeting | |
| Nov. 6-8 | Public Responsibility in Medicine and Research (PRIM&R) | PRIM&R Annual Conference | |
| Nov. 6-9 | American Society of Nephrology | Kidney Week | |
| Nov. 7-10 | American Heart Association | Scientific Sessions 2025 | |
| Nov. 7-11 | American Association for the Study of Liver Diseases | The Liver Meeting | |
| Nov. 18-19 | International Council for Harmonisation | ICH Assembly Meeting | |
| Nov. 19-20 | UMaryland, FDA | Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products |
PDUFA dates expected in October and November
PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application. The following PDUFA dates were obtained from a mix of publicly available sources, research and other sources.
| Date | Company | Drug | Indication |
| Sept. 30 | Fortress Biotech | CUTX-101 | Treatment of Menkes disease |
| Oct. 7 | Jazz Pharmaceuticals | Zepzelca plus Tecentriq | First-line maintenance treatment of extensive-stage small-cell lung cancer |
| Oct. 13 | Arcutis | Zoryve cream | Treatment of atopic dermatitis in children ages 2 to 5 |
| Oct. 19 | AstraZeneca and Amgen | TEZSPIRE | Treatment of patients with chronic rhinosinusitis with nasal polyps |
| Oct. 20 | Glaukos | Epioxa | Treatment of keratoconus |
| Oct. 23 | GSK | Blenrep | Treatment of patients with relapsed/refractory multiple myeloma |
| Oct. 25 | Merck | Winrevair | Labeling update related to pulmonary arterial hypertension (PAH) |
| Oct. 25 | Syndax | Revuforj | Treatment of relapsed or refractory mNPM1 acute myeloid leukemia |
| Oct. 31 | Roche | Gazyva/Gazyvaro | Treatment of lupus nephritis |
| Nov. 9 | REGENXBIO | RGX-121 (clemidsogene lanparvovec) | Treatment of mucopolysaccharidosis II (MPS II), a.k.a. Hunter syndrome |
| Nov. 18 | Arrowhead Pharmaceuticals | Plozasiran | Treatment of familial chylomicronemia syndrome (FCS) |
| Nov. 30 | GenMab | Epcoritamab plus R2 | Second-line treatment option for patients with relapsed/refractory follicular lymphoma |
| Nov. 30 | Kura Oncology and Kyowa Kirin | ziftomenib | Treatment of adult patients with relapsed or refractory NPM1-mutated AML |
| Nov. 30 | Ascendis Pharma | TransCon CNP | Treatment of children with achondroplasia |
User fee deliverables expected in October and November
The FDA has generally been meeting its commitments under its various new user fee programs, typically weeks or months ahead of schedule. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).
| Letter | Program Tag | Commitment | Due Date |
| BsUFA | Container closure systems | FDA will publish a draft guidance describing considerations for developing presentations, container closure systems and device constituent parts for proposed interchangeable biosimilar biological products. | Sept. 30 |
| GDUFA | Resource capacity planning | An independent contractor will complete and publish an evaluation of the resource capacity planning capability. | Sept. 30 |
| BsUFA | Resource planning | An independent contractor will complete and publish an evaluation of the resource capacity planning capability. | Sept. 30 |
| BsUFA | Financials | FDA is committed to reducing the carryover balance to no greater than 21 weeks of the target revenue. | Sept. 30 |
| BsUFA | Data | FDA will complete ESG transition to the cloud, including setup and integration of an enterprise Identity and Access Management solution that will streamline applicant access to FDA resources. | Sept. 30 |
| MDUFA | Hiring new staff | Hire 24 new staff. | Sept. 30 |
| PDUFA | Type D Meetings | Hold 70% of Type D meetings, or send written response, within 50 calendar days from receipt of meeting request. | Sept. 30 |
| PDUFA | INTERACT meetings | Hold 70% of INTERACT meetings, or send written response, within 75 calendar days from receipt of meeting request. | Sept. 30 |
| PDUFA | Use-Related Risk Analysis (URRA) | Review and notify sponsor of agreement or nonagreement with comments for 70% of filed submissions, within 60 days of receipt of submission. | Sept. 30 |
| PDUFA | Human Drug Review Program Hiring Goals | CBER: 29 targeted hires | Sept. 30 |
| PDUFA | Human Drug Review Program Hiring Goals | CDER: 15 targeted hires | Sept. 30 |
| MDUFA | Deficiency Letters | FDA will provide, consistent with updated guidance, deficiency letters for 85% of all deficiencies taking place in FY2025. Applies to Original PMA, Panel-Track Supplement, 510(k) and De Novo request submissions. | Sept. 30 |
| MDUFA | Total Product Life Cycle (TPLC) Advisory Program (TAP) | As part of TPLC pilot program effort: In FY 2025, continue to support products enrolled in previous fiscal years and expand to enroll up to 65 additional products in at least four OHTs (i.e., up to 125 total products enrolled through FY 2025). | Sept. 30 |
| BsUFA | BPD Type 2a | FDA will hold 70% of meetings or issue written response within 60 calendar days of receipt of meeting request and background package. | Sept. 30 |
| BsUFA | User-Related Risk Analysis | Review and notify sponsor of agreement or non-agreement with comments for 70% of filed submissions within 60 days of receipt of submission. | Sept. 30 |
| GDUFA | Suitability Petitions | FDA will review and respond to suitability petitions that have been assigned a goal date – 70% of submissions within 6 months after completeness assessment, up to a maximum of 70 suitability petitions completed. | Sept. 30 |
| GDUFA | Post-Warning Letter Meetings | FDA will decide to grant, deny or defer a Post-Warning Letter Meeting. It will respond to requests within 30 days for 70% of eligible requests. | Sept. 30 |
| GDUFA | Generic Drug Manufacturing Facility Reinspection | For 70% of the requests for domestic reinspection that are granted, FDA will reinspect the facility within 4 months of the letter to the facility indicating FDA’s intent to reinspect. | Sept. 30 |
| GDUFA | Generic Drug Manufacturing Facility Reinspection | For 70% of requests for international facility reinspection that are granted, FDA will reinspect the facility within 8 months of the letter to the facility indicating FDA’s intent to reinspect. | Sept. 30 |
| OMUFA | Hiring | Onboard 9 new staff (FTEs) in a fiscal year. | Sept. 30 |
| OMUFA | Review Performance | The second year in which Innovation OMORs will be associated with timelines and performance goals. FDA to issue a final order by the specified goal date in 75% of cases. | Sept. 30 |
| OMUFA | Review Performance | For 50% of resubmitted original OMORs received in Year 5 of the program, FDA will issue a final order by the specified goal date. | Sept. 30 |
| OMUFA | Meetings | FDA to hold 40 meetings requested by companies. | Sept. 30 |
| OMUFA | Meetings | FDA will meet 80% of the total of meeting management goal dates for the first 12 meetings held. | Sept. 30 |
| OMUFA | Review Performance | For 80% of OMOR submissions that request safety changes, and that are received in Year 5, FDA will issue a final order by the specified goal date. | Sept. 30 |
| OMUFA | Review Performance | For dispute resolution requests received in Year 5, FDA will meet 75% of the timeline dates described in the FDRR draft guidance. | Sept. 30 |
| BsUFA | Hiring | Public meeting to discuss report on the factors that contribute to HR successes and challenges, including factors outside of FDA’s control, including findings and agency’s plans to address recommendations. | Sept. 30 |
| PDUFA | Enhancing Capacity to Review Complex Innovative Designs | Publish draft guidance on the Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics. | Sept. 30 |
| PDUFA | Novel Approaches to Development of Cell and Gene Therapy | Issue a draft guidance on the evaluation of efficacy in small patient populations using novel trial designs and statistical methods, and how these concepts can be applied to more common diseases. | Sept. 30 |
| PDUFA | Novel Approaches to Development of Cell and Gene Therapy | Issue a draft guidance on methods and approaches (e.g., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products. | Sept. 30 |
| PDUFA | Expedited Programs for the Development of Regenerative Medicine Therapies | Update the Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions | Sept. 30 |
| PDUFA | Resource Capacity Planning Assessment | Independent contractor will complete and publish an evaluation of the resource capacity planning capability. | Sept. 30 |
| PDUFA | Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making | Workshop 2, Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making | Sept. 30 |
| PDUFA | Sentinel Initiative | Publish an update on facilitation of public and sponsor access to Sentinel’s distributed data network to conduct safety surveillance. | Sept. 30 |
| PDUFA | Sentinel Initiative | Analyze and report on the use of Sentinel for regulatory purposes, e.g., in the contexts of labeling changes, PMRs, or PMCs. | Sept. 30 |
| PDUFA | Leveraging Knowledge | Convene a public meeting to solicit the perspective of cell and gene therapy manufacturers on how individual sponsors might leverage internal prior knowledge and public knowledge, including Chemistry, Manufacturing, and Controls, nonclinical, and clinical knowledge, across therapeutic contexts to facilitate product development and application review. | Sept. 30 |
| PDUFA | Assessment of Hiring and Retention | Hold a public meeting to discuss the report on staff hiring and retention for the human drug review program, its findings, and the agency’s specific plans to address the report recommendations. | Sept. 30 |
| PDUFA | Electronic Submissions Gateway (ESG) | Complete ESG transition to the cloud, including setup and integration of an enterprise Identity and Access Management solution that will streamline applicant access to FDA resources. | Sept. 30 |
| OMUFA | Forecasting | Each year, FDA will publish a nonbinding listing of monograph issues FDA intends to address in the coming three years. For issues for which FDA anticipates that submission of data to FDA will likely be needed, FDA will include a date by which it will expect these data to be submitted. | Oct. 1 |
| OMUFA | Review Performance | Timelines and performance goals for industry-requested GRASE Finalization OMORs to begin. | Oct. 1 |
| BsUFA | Biosimilar and interchangeable products | FDA will hold a public meeting to review progress of the pilot of a regulatory science program broadly applicable to facilitating biosimilar and interchangeable biological product development. | Oct. 31 |
| BsUFA | Interchangeable products | FDA will hold a scientific workshop on the development of interchangeable products to help identify future needs. | Oct. 31 |
Upcoming (or overdue) legislative requirements due as of October
Congress often asks the FDA to release or hold guidance documents, regulations, reports, meetings, hearings or pilot programs as of specific dates. Many of these requirements will be met weeks or months before the actual due date. The following legislative requirements are due within the next two months.
| Legislation | Requirement | Due Date |
| FDORA, Section 3607 |
Seamless or Concurrent Clinical Trials: FDA must issue final guidance on the use of seamless, concurrent and other innovative clinical trial designs no later than 18 months after the close of the public comment period for draft guidance, which was due within 1 year of the enactment of FDORA. FDA never published the draft guidance, though FDA Commissioner Makary has been frequently talking about “continuous” clinical trials recently. |
Aug. 27, 2025 |
| FDORA, Section 2511 | Registration: FDA is directed to update regulations so that additional FDA registrations are required for foreign drug and device manufacturers, including manufacturing activities for drugs, devices and ingredients “regardless of whether the drug or device undergoes further manufacture … at a separate establishment outside the United States prior to being imported or offered for import into the United States.” | Dec. 29, 2024 |
| FDORA, Section 2512 | Shortages: FDA must review its policies related to drug or biologic expiration dates and issue draft guidance or revise existing guidance on stability testing data in drug and biological product submissions. The guidance will include recommendations on the inclusion of “the longest feasible expiration date supported by such data” in a drug’s label. | Dec. 29, 2023 |
Regulations under development and expected to be promulgated in or before October and November
The following regulations are taken from FDA’s bi-annual Unified Agenda and represent the agency’s estimate of when it would potentially release regulations that are under development. These estimates are non-binding (unless otherwise required by law) and are often not met. However, we include them since it can be helpful to understand which regulations the agency is working on and which are most likely to be released soon.
| Title and Stage | Synopsis* | Estimated Publication |
| Registration of Commercial Importers of Drugs; Good Importing Practice (Proposed Rule) | This proposed rulemaking meets the mandate of section 714 of the Food and Drug Administration Safety and Innovation Act and will establish registration and good importing practice requirements for commercial importers of drugs. Although manufacturers are subject to regulatory requirements to ensure such quality standards are met, there are few clear responsibilities for commercial importers of drugs to do the same. | Sept. 2025 |
| Protection of Human Subjects and Institutional Review Boards (Final Rule) | This rule will harmonize, to the extent practicable and consistent with other statutory provisions, certain provisions of FDA’s regulations on human subject protection and institutional review boards with the revised “Federal Policy for the Protection of Human Subjects” (the revised Common Rule (45 CFR part 46, subpart A)). The rule also finalizes minor amendments to related regulatory provisions. | Sept. 2025 |
| Investigational New Drug Applications; Exemptions for Clinical Investigations to Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic (Final Rule) | Researchers conducting studies of FDA-regulated products involving human subjects must, in some circumstances, meet requirements set out in FDA’s IND Application regulations. The rule is intended to broaden the regulatory criteria for studies exempt from IND requirements and provide clarity and consistency regarding when studies evaluating drug uses of products that are lawfully marketed as conventional foods, dietary supplements, or cosmetics are subject to IND review. | Oct. 2025 |
| Revocation of Methods of Analysis Regulation (Final Rule) | The final rule revokes 2.19 (21 CFR 2.19), which states that it is FDA policy to use the methods of analysis of the AOAC International as published in the 1980 edition of Official Methods of Analysis of the Association of Analytical Chemists for FDA enforcement programs when the method of analysis is not prescribed in a regulation. Repeal of this regulation would eliminate an unnecessary policy. | Oct. 2025 |
| Revocation of the Mutual Recognition of Pharmaceutical Good Manufacturing Practice, Medical Device Quality System Audit, and Certain Medical Device Product Evaluation Reports: U.S. and the E.C. (Final Rule) | FDA is proposing to revoke the regulations titled “Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community.” FDA is proposing this action because the existing regulations have either been superseded by the 2017 amended Mutual Recognition Agreement (pharmaceutical annex) or are unnecessary, and do not reflect current Agency practice. | Nov. 2025 |
*The synopsis of each rule draws from its abstract on the OIRA website.
FDA Information Collection Reviews open to public comment or recently cleared as of October
Under the Paperwork Reduction Act, the FDA is required to obtain public input on the forms it uses every three years. The following forms are under active review or have recently been cleared by the White House’s Office of Management and Budget.
To contact the author of this piece, please email Alec Gaffney ( agaffney@agencyiq.com).
To contact the editor of this piece, please email Jason Wermers ( jwermers@agencyiq.com).