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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, comment periods and more. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts.

What we expect to be talking about in July and August

Chevron Shakeout: Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine? We’re about to find out. The court’s decision on June 28 is going to cause a frantic re-evaluation at every regulatory agency in the federal government and in every court in the country. [ Read AgencyIQ’s analysis of the Loper Bright decision]
Unified Agenda: What regulations is the FDA expecting to release through the end of the year? We will soon know, thanks to the expected update of the government’s Spring Unified Agenda. In years past, the Spring agenda was published in June, with the Fall agenda following in December. However, given the Presidential election, we expect it may be published in July or August after it failed to emerge in June.
Medical Misinformation: FDA Commissioner ROBERT CALIFF has been heavily focused for much of the last two years on what he calls the negative health effects of medical misinformation. In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. [ Read AgencyIQ’s preview of this guidance here]
Good Guidance Practices Report: We’re expecting to receive a major and interesting report on the FDA’s Good Guidance Practices FDA by June 29. An earlier iteration of that report detailed how the agency wanted to change some of its practices surrounding the publication of guidance documents. However, the draft document was somewhat FDA-focused, and industry asked the agency to incorporate other ideas into the final version. We will see if FDA is willing to accept those changes later this month.
The Summer Slowdown: For regulatory professionals, July and August are that time of the year when the FDA actually slows down in noticeable ways. After an extremely busy June, the calendar of events FDA and industry groups have for July and August has noticeably slowed down

Things FDA expects to do in July and August

This list is comprised of specific actions and the dates by which FDA has said it plans to accomplish them.

Date	What’s Happening	Explanation	Source
June 29	GGP Report	FDA expected to finalize report on Good Guidance Practices	AgencyIQ
June 30	User Fee Payments	Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025	FDA
July 1	Anniversary	Anniversary of the signing of the Public Health Service Act of 1944	Wikipedia
July 21	Anniversary	Anniversary of the signing of Project BioShield	Wikipedia
July 5	Comment	FDA deadline to respond to new Project 5 in 5	FDA
July 31	FDA	Due date for submission of reports on drug/biologic production for 2023	FDA
August 7	FDA	Guidance on Covid-19 container closure systems (glass vials and stoppers) to expire.	FDA

Regulations and guidance under OIRA review as of July

The White House’s Office of Information and Regulatory Affairs (OIRA) 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	Legal Deadline
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers	Draft Guidance	May 21	None

Regulations and guidance awaiting immediate publication in July

The following documents have cleared review by the White House’s Office of Information and Regulatory Affairs (OIRA) and may be released by the FDA at any time. (Note: If a link no longer works, it is likely because OIRA has since deleted it.)

Title	Type	Date Cleared by OIRA	Legal Deadline
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers	Draft Guidance	May 21	None

Notable FDA Comment Periods Closing in July and August

FDA comment periods are typically open for 30-60 days, unless they are extended.

Title	Type	Comments Close
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564	Draft Guidance	July 5
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency	Draft Guidance	July 5
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments	Request for Comments	July 6
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry	Draft Guidances	July 16
Schedules of Controlled Substances: Rescheduling of Marijuana	Proposed Rule (DEA)	July 22
Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle	Request for Comments	July 22
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products	Draft Guidance	July 29
Considerations for the Use of Human-and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products	Draft Guidance	July 29
Platform Technology Designation Program; Draft Guidance for Industry	Draft Guidance	July 29
Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use	Proposed Order	July 29
Food and Drug Administration Information Technology Strategy and Customer Experience Strategy; Request for Comments	Notice	July 31
Risk Evaluation and Mitigation Strategy Logic Model: A Framework to Link Program Design With Assessment; Draft Guidance	Draft Guidance	August 5
Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring Inspections for Center for Biologics Evaluation and Research Submissions; Draft Guidance	Draft Guidance	August 5
Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance	Draft Guidance	August 5
Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing	Opportunity for Hearing	August 6
Listening Session: Optimizing the Food and Drug Administration’s Use of and Processes for Advisory Committees	Request for Comments	August 13
Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance	Draft Guidance	August 20
Best Practices for Meeting Management; Public Workshop; Request for Comments	Request for Comments	August 22

Meetings that FDA has planned for July and August

These are FDA-hosted events set to take place over the next two months.

Start Date	End Date	Event	Event Type	Center
07/10/2024	07/10/2024	Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method	Webcast	CDRH
07/10/2024	07/10/2024	FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care”	Webcast	Office of the Commissioner
07/11/2024	07/12/2024	Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products	Public	CDER
07/16/2024	07/16/2024	Webinar – In Vitro Diagnostic Product (IVD): Classification	Webcast	CDRH
07/22/2024	07/22/2024	Public Workshop: Best Practices for Meeting Management Under PDUFA VII	Workshop	CDER
07/23/2024	07/23/2024	Introduction to FDA’s Office of Trade and Global Partnerships	Virtual	CDER
07/25/2024	07/25/2024	Meeting of the Oncologic Drugs Advisory Committee (AstraZeneca’s IMFINZI)	Advisory Committee Meeting	CDER
07/25/2024	07/26/2024	FDA’s Fifth Online Controlled Substances Summit	Virtual	CDER
07/25/2024	07/25/2024	Virtual Public Meeting – Home as a Health Care Hub – Stakeholder Listening Session	Meeting	CDRH
07/25/2024	07/25/2024	Virtual Public Meeting – Home as a Health Care Hub – Stakeholder Listening Session	Meeting	CDRH
07/30/2024	07/30/2024	Environmental Monitoring in Compounding	Virtual	CDER
08/16/2024	08/16/2024	Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials	Meeting	CDER
08/21/2024	08/23/2024	2024 Compounding Quality Center of Excellence Annual Conference	Conference	CDER

Third-party regulatory meetings being held in July and August

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
July 11	UMaryland / FDA	Evaluating Immuno-suppressive Effects of In Utero Exposure to Drug and Biologic Products	Numerous
July 15-16	Alliance for Regenerative Medicine	Cell & Gene Congressional Fly-In	Nicole Verdun
July 18	Critical Path Institute	BYOD: A Guide for Successful Implementation
July 23-24	MDIC	Excellence in Quality Summit	Keisha Thomas, Daniel Walter, Erin Keith
July 25	Duke-Margolis	2024 State of Real-World Evidence Policy
July 25-26	Reagan-Udall Foundation for the FDA	Online Controlled Substances Summit	TBD
July 28 – August 1	Alzheimer’s Association	Alzheimer’s Association International Conference	Unknown
August 5	Sentinel	Overview of CDER’s Real-World Evidence Demonstration Projects
August 12-14	Pharma Conference Education	GMP By The Sea	Peter Marks, Emily Thakur, Alonzo Cruse, Numerous others
August 20	Duke-Margolis	Continual Improvement of CDER BLA Submission, Assessment, and Facility Readiness/ Inspection: CMC for Biologics & Biosimilars
August 22	HL7	REMS Public Meeting

PDUFA Dates expected in July and August

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 publicly available sources.

Date	Company	Drug	Indication
July 7	Arcutis	Roflumilast	Atopic Dermatitis in Adults and Children Down to Age 6
July 15	Orexo	OX124	High-dose rescue medication for opioid overdose
July 19	Phathom	VOQUEZNA	Daily treatment of heartburn associated with Non-Erosive gastroesophageal reflux disease (GERD) in adults
July 27	Alpha Cognition	ALPHA-1062	Mild-to-moderate Alzheimer’s disease
August 4	Adaptimmune	Afami-cel	Treatment of Advanced Synovial Sarcoma
August 10	Humacyte	Human Acellular Vessel	Treatment of Vascular Trauma
August 13	Citius Pharma	LYMPHIR	Treatment of patients with persistent or recurrent CTCL
August 14	Ascendis Pharma	TransCon PTH	Adults with hypoparathyroidism
August 14	Gilead Sciences	Seladelpar	Treatment of Primary Biliary Cholangitis
August 20	Servier	Vorasidenib	Treatment of IDH-mutant diffuse glioma
August 22	Regeneron	Linvoseltamab	Relapsed/Refractory Multiple Myeloma
August 28	Incyte, Syndax Pharmaceuticals	Axatilimab	cGVHD

User Fee Deliverables expected in July and August

FDA has generally been meeting its commitments under its various new user fee programs, and 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
PDUFA	Advancing RWE Program	Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER. (Completed)	June 30, 2024
GDUFA	Facility related CRL	FDA will issue a MAPP on the process for Reclassification of Facility-Based Major CRL Amendments set forth in section II(C)(7) (Complete)	June 30, 2024
GDUFA	Facility related CRL	FDA will issue a MAPP on the prioritization of FDA assessment of solicited DMF amendments (Completed)	June 30, 2024
PDUFA	Meetings	Hold a public meeting to discuss best practices for meeting management, including issues related to submission of meeting requests, efficient time management, coordinating meeting agenda, development and submission of meeting background packages and lessons learned from the Covid-19 pandemic including virtual meeting platforms (Scheduled)	July 30, 2024

Upcoming (or overdue) legislative requirements due as of July and August

Congress often asks the FDA to release or hold guidance documents, regulation, 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 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 FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label.	12/29/2023
FDORA, Section 3202	Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.	6/29/2024
FDORA, Section 3210	FDA must publish draft guidance on how sponsor questions about novel surrogate or intermediate endpoints can be answered earlier in the development process, as well as other factors related to the accelerated approval process.	6/29/2024

Overdue and pending regulatory actions

This list, based on the federal government’s Unified Agenda, contains all the regulations that FDA has said it intended to release, or plans to release in the coming months. In our experience, the FDA does not meet its own intended deadlines for the release of these actions in more than half of all cases (sometimes due to delays at the White House reviewing regulations). We’ve also included documents that are actively under White House review – a process which often takes several weeks (or months) to conclude. [ Read the full list of documents on FDA’s Unified Agenda here.]

Agenda Stage of Rulemaking	Title	Status	Estimated Publication
Proposed Rule	Medical Devices; Cardiovascular Devices; Classification of More Than Minimally Manipulated Allograft Heart Valves	Past Due	November 2023
Proposed Rule	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.	Past Due	November 2023
Prerule	Recalls of Products Subject to the Jurisdiction of the Food and Drug Administration	Past Due	November 2023
Proposed Rule	Current Good Manufacturing Practice for Positron Emission Tomography Drugs	Past Due	December 2023
Proposed Rule	Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act	Past Due	December 2023
Proposed Rule	Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness	Past Due	December 2023
Proposed Rule	Amendment to Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications	Past Due	January 2024
Proposed Rule	Registration of Commercial Importers of Drugs; Good Importing Practice	Past Due	January 2024
Final Rule	Revocation of Methods of Analysis Regulation	Past Due	January 2024
Final Rule	Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices	Past Due	January 2024
Proposed Rule	Requirements for Requesting Records in Advance of or in Lieu of an Inspection, and Participation in a Remote Interactive Evaluation, of an Establishment that Manufactures Certain HCT/Ps	Past Due	March 2024
Final Rule	Sunlamp Products; Amendment to the Performance Standard	Past Due	March 2024
Final Rule	General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products	Past Due	March 2024
Proposed Rule	Biologics Regulation Modernization	Past Due	April 2024
Proposed Rule	Contact Lens Devices; Designation of Special Controls for Daily Wear Contact Lenses	Past Due	April 2024
Final Rule	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	Past Due	April 2024
Final Rule	Nonprescription Drug Product With an Additional Condition for Nonprescription Use	Past Due	April 2024
Final Rule	Color Additive Certification; Increase in Fees for Certification Services	Past Due	April 2024
Proposed Rule	Post Approval Changes to Approved Applications	Past Due	May 2024
Proposed Rule	Clinical Holds in Medical Device Investigations	Past Due	June 2024
Proposed Rule	Amending Regulations That Require Multiple Copies Submissions	Past Due	June 2024
Final Rule	Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Drug Monograph	Past Due	June 2024
Final Rule	Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests	Past Due	June 2024
Proposed Rule	Revisions to Regulation for Receiving an Abbreviated New Drug Application		August 2024
Proposed Rule	Conduct of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies		August 2024
Final Rule	Revising the National Drug Code Format and Drug Labeling Barcode Requirements		August 2024

To contact the author of this piece, please email Alec Gaffney (agaffney@agencyiq.com)

What We Expect the FDA to do in July and August 2024