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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 May and June

Reaction to FDA LDT regulation: With the publication of the FDA’s final Laboratory Developed Test (LDT) rule in late April, we’re expecting the first few weeks of the May to be consumed with industry reactions to the rule, including likely litigation from the laboratories industry to halt its implementation period. Beyond litigation, expect that CDRH Director JEFF SHUREN could be called before House legislators who have already expressed displeasure at the rule.
FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.
A new era for DTC advertising: On May 20, the FDA’s final rule requiring that direct-to-consumer television and radio advertising contain “clear, conspicuous and neutral” statements regarding the drug’s major side effects and contraindications will go into effect. While not all advertisements will contain the new statements immediately (it is only required later in 2024), the changes will mark one of the most visible changes to drug advertising in years.
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 is typically published in June, with the Fall agenda following in December.

Things FDA expects to do in May and June

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
May 20	New advertising rule goes into effect	The first date by which companies may begin to advertise drugs using FDA’s new final rule on clear, conspicuous, and neutral statements.	FDA
June 29	GGP Report	FDA expected to finalize report on Good Guidance Practices	AgencyIQ

Regulations and guidance under OIRA review as of May

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
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies	Guidance	April 10	December 29 (Overdue)

Regulations and guidance awaiting immediate publication in May

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
None

Notable FDA Comment Periods Closing in May and June

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

Title	Type	Comments Close
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards	Draft Guidance	April 30
Early Alzheimer’s Disease: Developing Drugs for Treatment	Draft Guidance	May 13
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act	Draft Guidance	May 13
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products	Draft Guidance	May 13
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling	Draft Guidance	May 14
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program	Draft Guidance	May 14
Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior	Proposed Rule	May 28
Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples	Draft Guidance	May 28
Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions	Draft Guidance	May 28
New Dietary Ingredient Notification Master Files for Dietary Supplements	Draft Guidance	June 3
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act	Proposed Rule	June 18
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products	Draft Guidance	June 18
Fiscal Year 2024 Generic Drug Science and Research Initiatives Workshop; Public Workshop	Request for Comment	June 21
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry	Draft Guidance	June 24
Cancer Clinical Trial Eligibility Criteria: Performance Status	Draft Guidance	June 25
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications	Draft Guidance	June 25
Cancer Clinical Trial Eligibility Criteria: Laboratory Values	Draft Guidance	June 25
Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration’s Office of Clinical Pharmacology	Request for Comments	June 25
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications	Draft Guidance	June 28

Meetings that FDA has planned for May and June

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

Start Date	End Date	Event	Event Type	Center
04/29/2024	04/29/2024	Medical Device Sterilization Town Hall: Topics and Formats for the Continuing Sterilization Series	Town Hall	CDRH
04/30/2024	04/30/2024	Webinar – Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act	Webcast	CDRH
05/01/2024	05/01/2024	2024 FDA & ASCPT Annual William B. Abrams Lecture: The Benzodiazepine Era	Other	Office of the Commissioner
05/02/2024	05/03/2024	FDA/CRCG Workshop: Considerations and Potential Regulatory Applications for a Model Master File	Public	CDER
05/07/2024	05/08/2024	Drug Development Considerations for the Treatment of Congenital Cytomegalovirus Infection and Neonatal Enterovirus Infection	Public	CDER
05/08/2024	05/09/2024	Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment \| Role and Opportunities	Public	CDER
05/09/2024	05/09/2024	FDA Grand Rounds: Whole Genome Sequencing: A Powerful Scientific Tool that Delivered During the 2023 Pseudomonas Outbreak in Eye Drops	Webcast	Office of the Commissioner
05/09/2024	05/09/2024	Public Workshop: In-person and Hybrid How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases	Workshop	Office of the Commissioner
05/09/2024	05/09/2024	Blood Products Advisory Committee May 9, 2024 Meeting Announcement	Advisory Committee Meeting	CBER
05/09/2024	05/09/2024	Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval	Virtual	CDER
05/09/2024	05/09/2024	Improving the Diagnosis and Treatment of Women with Myocardial Ischemia and Non-obstructive Coronary Arteries	Webcast	Office of the Commissioner
05/13/2024	05/13/2024	Natural History Studies and Registries in the Development of Rare Disease Treatments	Workshop	CDER
05/14/2024	05/14/2024	Webinar – Final Rule: Medical Devices; Laboratory Developed Tests	Webcast	CDRH
05/16/2024	05/16/2024	Vaccines and Related Biological Products Advisory Committee (Seasonal Covid-19 Vaccines)	Advisory Committee Meeting	CBER
05/16/2024	05/16/2024	Osteoporosis: A Perspective for 2024	Scientific	Office of the Commissioner
05/16/2024	05/16/2024	Statistical Considerations for Premarketing Risk Assessment	Virtual	CDER
05/20/2024	05/21/2024	Fiscal Year 2024 Generic Drug Science and Research Initiatives Public Workshop	Workshop	CDER
05/22/2024	05/22/2024	Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (Pediatric Targeted Oncology)	Advisory Committee Meeting	CDER
05/23/2024	05/23/2024	Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee (Guardant Shield Blood Collection Kit)	Advisory Committee Meeting	CDRH
05/24/2024	05/24/2024	Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (Novo Nordisk’s insulin icodec)	Advisory Committee Meeting	CDER
05/29/2024	05/30/2024	Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development	Conference	CDER
06/04/2024	06/04/2024	OTP Town Hall: CMC Readiness for Gene Therapy BLAs	Town Hall	CBER
06/06/2024	06/06/2024	2024 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments	Meeting	CDER
06/13/2024	06/13/2024	Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees	Listening Session
06/13/2024	06/13/2024	OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites	Workshop	CDER
06/13/2024	06/13/2024	FDA Oncology Center of Excellence Presents Conversations on Cancer, 4th Annual National Black Family Cancer Awareness Week, Engaging the Generations, #BlackFamCan	Webcast	Office of the Commissioner
06/18/2024	06/18/2024	FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference	Conference	Office of Regulatory Affairs

Third-party regulatory meetings being held in May and June

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
April 29 – May 1	Global Genes	Rare Drug Development Symposium
April 29 – May 1	Dark Report	Executive War College on Diagnostics, Clinical Laboratory and Pathology Management
April 30 – May 2	Archimedes Center for Health Care and Medical Device Cybersecurity	Archimedes 101 Health Care Security Week	Natassia Tamari
May 1	Alliance for a Stronger FDA	Alliance’s FY 25 Budget Series: ORA’s Michael Rogers	Michael Rogers
May 2-3	UMaryland	Considerations and Potential Regulatory Applications for a Model Master File
May 2	SOCRA	17th Annual Device Research & Regulatory Conference	Gail Rodriguez, Donna Headlee
May 3-6	ACRP	ACRP 2024
May 6	Alliance for a Stronger FDA	Alliance’s FY 25 Budget Series: CDER’s Dr. Patrizia Cavazzoni	Patrizia Cavazzoni
May 6	Friends of Cancer Research; Parker Institute for Cancer Immunotherapy	Unlocking Complex Cell-based Gene Therapies	Peter Marks, Namandjé Bumpus, Nicole Verdun, Iwen Wu, Asha Das, Anna Kwilas,
May 6-9	Association of Public Health Laboratories	APHL Annual Conference	Numerous
May 7	Reagan-Udall Foundation for the FDA	2024 Annual Public Meeting	Robert Califf, Jim Jones, Peter Marks, Jeff Shuren, Douglas Stearn, Marta Sokolowska
May 7-11	ASGCT	ASGCT Annual Meeting	Ingrid Markovic,
May 7-8	Pharma Conference Inc	19th Annual FDA and the Changing Paradigm for HCT/P Regulation
May 8-9	UMaryland	Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment
May 13-16	AAPS	National Biotechnology Conference	Celia Witten
May 13	Reagan-Udall Foundation	Natural History Studies and Registries in the Development of Rare Disease Treatments
May 14	Alliance for a Stronger FDA	Alliance’s FY 25 Budget Series: CDRH Director Dr. Jeff Shuren	Jeff Shuren
May 14	America’s Blood Centers	2024 ADRP Annual Conference
May 15-16	FDLI	2024 FDLI Annual Conference	Robert Califf, Mark Raza, Julie Tierney, Patrizia Cavazzoni, Jeff Shuren, others
May 16	GBS\|CIDP Foundation International	Patient Focused Drug Development Meeting: Rare, Autoimmune Peripheral Neuropathies: Guillain-Barre Syndrome (GBS), Multifocal Motor Neuropathy (MMN), and Anti-myeline-associated glycoprotein (Anti-MAG) neuropathy
May 20	National Academies	Toward a Framework to Improve Diversity and Inclusion in Clinical Trials – A Workshop
May 21	DIA	Regulatory Policy and Intelligence Community Meeting: OND Director Peter Stein	Peter Stein
May 22	AgencyIQ	Monthly Webinar (Topic TBD)
May 22	NPA	2024 NPA Fly-In Day
May 28	The Global Foundation for Peroxisomal Disorders	Patient Focused Drug Development Meeting: Peroxisomal Disorders
May 30	Reagan-Udall Foundation for the FDA	Real-World Evidence Webinar Series: Considerations Regarding Non-Interventional Studies for Drug and Biological Products	John Concato, Tala Fakhouri, Stefanie Kraus
May 31 – June 4	ASCO	2024 ASCO Annual Meeting	Richard Pazdur
June 3-6	BIO	BIO Annual Convention	Patrizia Cavazzoni, Peter Marks, others
June 3-5	MedTech Intelligence	Medical Device Regulatory Intelligence Summit
June 4-5	ICH	ICH Assembly Meeting
June 6-7	RAPS	Regulatory Intelligence Conference	AgencyIQ Speakers
June 7	Myositis Support and Understanding	Patient Focused Drug Development Meeting: Adult Dermatomyositis
June 11	SADS Foundation	Patient Focused Drug Development Meeting: Long QT Syndrome (LQTS) and Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
June 16-20	DIA	DIA Global Annual Meeting	Numerous. AgencyIQ also in attendance.
June 17-18	ISPE	2024 ISPE Biotechnology Conference	Sharmista Chatterjee
June 18-20	SOCRA	FDA Clinical Trial Requirements, Regulations, Compliance and GCP Virtual Conference	Numerous
June 18	GovTech Connects	FedFocus ’24: FDA-ODT: New Acquisition Strategy, IT Operating Plan & Implementation Plan	Vid Desai, Jessicva Berrellez, others
June 24-26	Council for Responsible Nutrition	12th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements	Cara Welch
June 25	AgencyIQ	Monthly Webinar (Topic TBD)

PDUFA Dates expected in May and June

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
May 9	Seagen / Astellas	PADCEV	First-Line Treatment of Advanced Bladder Cancer
May 9	Pfizer / Genmab	TIVDAK	Recurrent or metastatic cervical cancer with disease progression on or after first-line therapy
May 9	Merck	KEYTRUDA	First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer
May 13	Dynavax	HEPLISAV-B	Hepatitis B vaccine for patients on hemodialysis
May 14	Ascendis Pharma	TransCon PTH	Adult patients with hypoparathyroidism.
May 23	BMS	Breyanzi	Relapsed or Refractory Follicular Lymphoma (FL)
May 25	Abeona Therapeutics	Pz-Cel	recessive dystrophic epidermolysis bullosa (RDEB)
May 31	BMS	Breyanzi	Relapsed or Refractory Mantle Cell Lymphoma (MCL)
June 4	Catalyst Pharmaceuticals	Firdapse	Treatment of Lambert-Eaton myasthenic syndrome (“LEMS”)
June 7	GSK	AREXVY	Prevention of RSV Disease in Adults Aged 50-59 at Increased Risk
June 10	Ipsen and Genfit	elafibranor	Treatment of rare cholestatic liver disease, PBC
June 12	Amgen	Tarlatamab	Third-Line Treatment of Advanced SCLC
June 15	BMS	Augtyro	Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors
June 16	Geron	Imetelstat	Treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS)
June 17	Merck	V116	21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults
June 21	Zai Lab	KRAZATI (Adagrasib)	Treatment of patients with previously treated KRAS^G12C-mutated locally advanced or metastatic colorectal cancer (CRC)
June 21	Argenx	VYVGART Hytrulo	Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
June 21	Harmony Biosciences	WAKIX (pitolisant)	Treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients 6 years of age and older with narcolepsy
June 21	Zevra Therapeutics	Arimoclomol	Treatment For Niemann-Pick Disease Type C
June 21	Merck	KEYTRUDA (pembrolizumab)	Treatment for Primary Advanced or Recurrent Endometrial Carcinoma
June 26	Merck/ Daiichi Sankyo	patritumab deruxtecan	treatment of certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC)
June 26	Verona Pharma	ensifentrine	The maintenance treatment of patients with chronic obstructive pulmonary disease
June 27	Sanofi	Dupixent	treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD)
June 28	Genmab	EPKINLY (Epcoritamab)	Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma
June 30	Rocket Pharmaceuticals	KRESLADI (marnetegragene autotemcel)	Treatment of Severe Leukocyte Adhesion Deficiency-I (LAD-I)

User Fee Deliverables expected in May and June

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.	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)	June 30, 2024
GDUFA	Facility related CRL	FDA will issue a MAPP on the prioritization of FDA assessment of solicited DMF amendments	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	July 30, 2024

Upcoming (or overdue) legislative requirements due as of May

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 2503	Platform Technologies: FDA must issue draft guidance regarding the implementation of the platform technology designation program. The guidance will include examples of products that can use platform technologies, information on the Agency’s review process, and recommendations and requirements for reporting.	12/29/2023
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 3602	Clinical Trials Diversity: FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies. The guidance will include information for sponsors regarding both formatting and content. The content will include both goals for enrollment of populations and rationales for those goals.	12/29/2023
FDORA, Section 3202	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
FDORA, Section 3612	FDA must issue draft guidance on the Agency’s processes and practices for Bioresearch Monitoring (BIMO) inspections, which received new authorities in the omnibus. The guidance will cover best practices for information submission and other communications.	6/29/2024
FDORA, Section 3614	GAO will submit a report to Congress on inspections of foreign facilities conducted by foreign establishments. The report will cover topics such as frequency and manner of these inspection, as well as other considerations such as mutual recognition agreements.	6/29/2024
FDORA, Section 3628	GAO will submit a report to Congress assessing “the policies and practices of the Division of Executive Operations of the Office of the Executive Secretariat of the Food and Drug Administration with respect to the receipt, tracking, managing, and prioritization of correspondence.”	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
Final Rule	Administrative Destruction of Certain Devices Refused Admission to the United States	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	Biologics License Applications and Master Files	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		May 2024
Proposed Rule	Clinical Holds in Medical Device Investigations		June 2024
Proposed Rule	Amending Regulations That Require Multiple Copies Submissions		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		June 2024
Final Rule	Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests		June 2024

To contact the author of this piece, please email Alec Gaffney ( [email protected])

What We Expect the FDA to do in May and June 2024