What We Expect the FDA to do in December 2023

In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month 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.

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST

Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. We will also be providing semi-regular updates to this page during the first half of each month.

What we expect to be talking about in December and January:

  • Diversity Action Plan guidance: There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published.
  • Government shutdown: At present, the FDA has appropriated funding through January 19. That means at 12:01 on January 20, the FDA will shut down unless Congress is able to pass a funding bill for the agenda or a continuing resolution. There are plenty of reasons to think that Congress won’t be able to come to an agreement on this FDA-Agriculture funding bill given ongoing disagreements regarding its scope and the inclusion of certain abortion-related provisions.
  • The end-of-year crush: The end of the calendar year is always a busy time, and it will be especially busy this year. The December calendar is packed with regulatory and industry meetings. December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. And there’s quite a lot left on CBER and CDER’s annual guidance agendas to get through as well. December also typically brings end-of-year perspectives on the agency’s accomplishments.
  • Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. The FDA has said in court filings that it plans to make a decision about Florida’s prescription drug importation proposal in December, and recently pushed back a response date related to a similar plan from Colorado. Whatever the agency decides could result in new lawsuits or negative political attention.
  • Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. This is already proving to be one of the FDA’s most-opposed actions in years.

Things FDA expects to do in December:

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

December 11

Digital Health Advisory Committee

The due date for applications to join FDA’s new Digital Health Advisory Commitee

FDA

December 30

Artificial Intelligence

Date by which FDA must have designated a Chief AI Officer, convene relevant senior officials to coordinate and govern AI issues, and more.

OMB

December 31

FDA deadline on Florida drug importation plan

The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan some time in December.

AgencyIQ

Regulations and guidance under OIRA review as of December

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

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

August 29

None

Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

Final Rule

September 7

None

Stimulant Use Disorders: Developing Drugs for Treatment

Draft Guidance

September 15

None

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Draft Guidance

October 23

None

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Draft Guidance

October 23

None

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

Guidance

November 8

None

Key Information and Facilitating Understanding in Informed Consent for Food and Drug Administration-Regulated Clinical Investigations

Guidance

November 22

None

Regulations and guidance awaiting immediate publication in December

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 December and January

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

Title

Type

Comments Close

Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop

RFI

November 30

Medical Devices; Laboratory Developed Tests

Rule

December 4

Stimulant Use Disorders: Developing Drugs for Treatment

Guidance

December 4

Modernizing the Food and Drug Administration’s Premarket Notification Program

Notice

December 6

Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council of Harmonisation E2B(R3) Standards; Public Meeting

Request for Comments

December 6

Modernizing the Food and Drug Administration’s Premarket Notification Program

Notice

December 6

Evidentiary Expectations for 510(k) Implant Devices

Guidance

December 6

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

Guidance

December 6

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

Guidance

December 6

Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2022 Proposed Guidance Development

Notice

December 11

Advisory Committee; Digital Health Committee; Establishment

Request for Nominations

December 11

Adherence Potential and Patient Preference in Prescription Drug Promotion

Proposed Study

December 11

Clinical Pharmacology Considerations for Peptide Drug Products

Guidance

December 11

Quality Considerations for Topical Ophthalmic Drug Products

Guidance

December 13

Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket

Request for Comments

December 14

Labeling for Biosimilar and Interchangeable Biosimilar Products

Guidance

December 18

Diabetic Foot Infections: Developing Drugs for Treatment

Guidance

December 18

Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence

Guidance

December 18

Regulatory Considerations for Prescription Drug Use-Related Software

Guidance

December 18

Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products

Guidance

December 21

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers

Guidance

December 24

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities

Guidance

December 26

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance

 

January 5

Product-Specific Guidances; Draft and Revised Draft Guidances for Industry

Guidance

January 16

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff; Availability

Guidance

January 16

Workshop To Enhance Clinical Study Diversity; Public Workshop

Request for Comment

January 29

Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes

 

January 31

Meetings that FDA has planned for December and January

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

Start Date

End Date

Event

Event Type

Center

11/28/2023

11/29/2023

UGA/FDA 10th Annual Medical Device Regulations Conference

Joint Regulatory

Office of Regulatory Affairs

11/28/2023

11/28/2023

Toward Global IDMP Implementation: A Focus on Global Use Cases

Virtual

CDER

11/28/2023

11/28/2023

Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS)

Webinar

CDER

11/29/2023

11/29/2023

Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee

Advisory Committee Meeting

CDRH

11/29/2023

11/30/2023

Discussing Approaches to Enhance Clinical Study Diversity Public Workshop

Webcast

CDER

11/30/2023

12/01/2023

Advancing the Development of Pediatric Therapeutics (ADEPT) 8 Workshop on Drug Dosing in Pediatric Patients with Renal Impairment

Workshop

CDER

11/30/2023

11/30/2023

Conversations on Cancer: How Biotech Built a Blockbuster Cancer Drug

Webcast

Office of the Commissioner

12/04/2023

12/07/2023

2023 FDA Digital Transformation Symposium

Virtual

Office of the Commissioner

12/05/2023

12/05/2023

Immediately-in-effect guidance: Antimicrobial Susceptibility Test System Devices – Updating Breakpoints in Device Labeling

Webcast

CDRH

12/06/2023

12/07/2023

FDA Clinical Investigator Training Course (CITC) 2023

Conference

CDER

12/06/2023

12/06/2023

Collaborating on Culture in the New Era of Smarter Food Safety

Webcast

Office of the Commissioner

12/12/2023

12/13/2023

Adult Attention-Deficit/Hyperactivity Disorder: Diagnosis, Treatment, and Implications for Drug Development Workshop

Workshop

CDER

12/12/2023

12/13/2023

Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources

Virtual

CDER

12/12/2023

12/12/2023

Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program

Webcast

CDRH

12/14/2023

12/14/2023

Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement

Virtual

CDER

12/14/2023

12/14/2023

FDA Grand Rounds: FDA Approach to the Safety Assessment of Food Ingredients

Webcast

Office of the Commissioner

01/11/2024

01/11/2024

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance

Webcast

CDRH

01/23/2024

01/25/2024

FDA CASSS Interface of Regulatory and Analytical Sciences for Biotechnology Health Products

Symposium

CBER

Third-party regulatory meetings being held in December and January

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

November 28

RAPS-AFDO

Combination Products Summit

Numerous

November 29-30

CTTI-FDA-Duke

Virtual Public Workshop On Enhancing Clinical Study Diversity

Karen Hicks, Patrizia Cavazzoni, Mathilda Fienkeng,

November 30

HL7

REMS Public Call

 

November 30

C-Path

2023 C-Path Neuroscience Annual Meeting

 

December 2

RAPS/AFDO

Combination Products Summit

Steven Oh, Aftin Ross, John Weiner, James Bertram, Thinh Nguyen

December 3-6

PRIM&R

Annual Conference

Kevin A. Prohaska, Kavita C. Dada, Laurie Muldowney

December 4

Alliance for a Stronger FDA

Webinar with Peter Marks

Peter Marks

December 4-5

NASEM

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union

 

December 4-5

ISOP

7th ISoP Intelligent Automation in Pharmacovigilance Seminar

 

December 5

Reagan-Udall Foundation

2023 Innovations in Regulatory Science Awards

 

December 6

BEST Initiative

Use of Linked Databases in Pharmacoepidemiology: Considerations for Potential Selection Bias

 

December 6

FDA Alumni Association

Winter Celebration

 

December 6

Natural Products Association

Behind the Administrative Iron Curtain of the FDA and FTC

 

December 6-7

FDLI

Enforcement, Litigation, and Compliance Conference

Numerous

December 7-8

UMaryland, FDA

Characterization of Complex Excipients and Formulations

TBD

December 11-12

ISPE

2023 ISPE Pharma 4.0 and Annex 1 Conference

Joel Welch

December 12

AgencyIQ

Looking ahead to 2024: Regulatory Forecast for the U.S. and the EU

AgencyIQ Staff

December 12

Duke-Margolis

Improving Regulatory Practices to Sustain Antibiotic Innovation

TBD

December 12

Biocom California

Regulatory Affairs Committee Meeting: FDA’s TAP Pilot Program

Kai Kadoich

December 14

Duke-Margolis

Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement

TBD

December 18

RAPS

RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024

AgencyIQ Speakers

December 19

NIST

Virtual Listening Session for the U.S. Government National Standards Strategy for Critical and Emerging Technology

 

December 21

HL7

REMS Public Call

 

January 7

UCSF

2024 CERSI Innovations in Regulatory Science Summit

Robert Califf, Janet Woodcock, Namandje Bumpus, Peter Marks, Patrizia Cavazzoni, Jeff Shuren, Doug Kelly, Tina Morrison,

January 8

UCSF

2024 CERSI Scientific Symposium

Tina Morrison

January 8

Alliance for Regenerative Medicine

Cell & Gene State of the Industry Briefing

 

January 8-11

J.P. Morgan Chase

42nd Annual J.P. Morgan Healthcare Conference

 

January 18-19

CCOI

Collaborative Community on Ophthalmic Imaging Virtual Conference

Michelle Tarver, Malvina Eydelman,

January 22

DIA

DIA/Harvard-MIT CRS Accelerating Cell and Gene Therapy Executive Roundtable

 

January 23

Duke-Margolis

Advancing Drug Development for the Prevention of Spontaneous Preterm Birth

 

January 26

Ree Wynn Foundation

Externally Led PFDD Meeting: Immune Thrombotic Thrombocytopenic Purpura (iTTP)

 

January 31

Duke-Margolis

Building Quality into the Design and Conduct of Clinical Studies: Integrating Quality by Design (QbD) and Risk-Based Monitoring (RBM) Approaches

 

PDUFA Dates expected in December and January

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

November 30

Takeda/HUTCHMED

Fruquintinib

December 8

Vertex / CRISPR Therapeutics

Exagamglogene autotemcel

December 16

Arcutis

Roflumilast

December 16

Optinose

XHANCE

December 16

Merck

KEYTRUDA

Delayed (Orig. Dec. 16)

BMS

Abecma

December 20

Bluebird Bio

Lovotibeglogene

December 20

Calliditas

Tarpeyo

December 22

Glaukos

iDose TR

December 22

Ionis

Eplontersen

December 24

Amgen

Lumakras

December 27

Merck

Gefapixant

December 30

Zealand Pharma

Dasiglucagon

January 3

Fortress Biotech, Checkpoint Therapeutics

Cosibelimab

January 5

Novan, Ligand

Berdazimer Gel

January 17

Merck

WELIREG

January 17

Satsuma

Dihydroergotamine nasal powder

January 20

Merck

KEYTRUDA

January 22

Theratechnologies

Tesamorelin F8

January 23

Heron Therapeutics

ZYNRELEF

January 24

Liquidia Corporation

YUTREPIA

January 31

Sanofi, Regeneron

Dupixent

User Fee Deliverables expected in December and January

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

BsUFA

Communication

FDA will update relevant guidances, MAPPs and SOPPs, as appropriate, regarding best practices in comminication based on BsUFA II final assessment

December 31, 2023

 

PDUFA

Enhancing the Incorporation of the Patient’s Voice in Drug Development and Decision-Making

Issue a Federal Register Notice summarizing the input to the RFI to elicit public input on methodological issues, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, and other areas of greatest interest or concern to public stakeholders

December 31, 2023

PDUFA

Cloud-based technology

Publish findings of assessment of challenges or barriers in FDA’s adoption of cloud-based technologies in applicant-regulator interactions

December 31, 2023

MDUFA

Alignment on use of MDUFA carryover funds

No less than annually, FDA and industry will work together to seek alignment on how best to utilize available funds in the carryover balance to improve the process for the review of device applications – e.g., performance on submission types with performance goals and/or quality management programs.

Begins December 31, 2023

MDUFA

Deficiency Letters

An annual audit shall take place regarding the extent to which FDA has met performance targets for sending deficiency letters to applicants. FDA will review each fiscal year’s audit results with industry no later than the first quarterly meeting of the following fiscal year.

Begins December 31, 2023

MDUFA

ASCA Pilot Program

FDA will report annually on the progress of the Accreditation Scheme for Conformity Assessment (ASCA) Program.

Begins December 31, 2023

Upcoming legislative requirements due as of December and January

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 2502

The pandemic: The omnibus text codifies FDA’s authority to consult or enter into agreements with third parties to assist in evaluation and review of Emergency Use Authorization (EUA) submissions for In Vitro Diagnostics. FDA is directed to issue draft guidance on consultations with these third parties that includes ethical, financial, and information sharing aspects.

12/29/2023

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 2505

Good Guidance Practices: FDA is directed to develop and publicize a “best practices” report and implementation plan for identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, within centers, across the Food and Drug Administration, and across other applicable agencies, as well as a plan to implement such best practices. This report is due in draft form within one year.

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 3016

Advanced Manufacturing Technologies Designation Program: FDA is directed to designate up to five National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, which are institutions or consortia who will receive grants to provide leadership, conduct advanced research, and facilitate education and training in this subject area.

12/29/2023

FDORA, Section 3210

Accelerated Approval: FDA’s Accelerated Approval Council must publish a report within one year of the passage of the FDORA legislation regarding its annual activities.

12/29/2023

FDORA, Section 3213

Advanced Manufacturing Technologies Designation Program: Within one year of the passage of FDORA, FDA must initiate the Advanced Manufacturing Technologies Designation Program, through which the Agency will review and designate as advanced methods of manufacturing drugs, biologics, and ingredients meeting certain novelty criteria.

12/29/2023

FDORA, Section 3305

Medical Device Cybersecurity: GAO will publish a report “identifying challenges in cybersecurity for devices, including legacy devices.” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

12/29/2023

FDORA, Section 3602

Clinical Trials Modernization: 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 3603

Clinical Trials Modernization: FDA is directed to convene at least one public workshop to solicit input from stakeholders on “increasing enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups, where appropriate.” The meeting(s) must take place within one year of FDORA’s passage, and a public docket must remain open for at least 60 days.

12/29/2023

FDORA, Section 3607

Clinical Trials Modernization: FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” These include the use of expansion cohorts, concurrent trial conduct, and other designs. The guidance should also include information on how the Agency will assess data collected through these designs.

12/29/2023

FDORA, Section 3611

Inspections: FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection. The guidance should include a description of processes for how companies can respond to its requests and factors that FDA will consider for evaluating the timeliness or completeness of a company’s response to its request.

12/29/2023

FDORA, Section 3629

Real-World Data and Real-World Evidence: FDA must update or issue guidance with considerations for the use of real-world data and real world evidence for decision making. The guidance will cover considerations for standards and methodologies for using RWE in regulatory decision making for drugs and biologics (with a focus on those authorized for emergency use) and devices.

12/29/2023

FDORA, Section 3202

Orphan Drug Program: FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

12/31/2023

FDORA, Section 3617

Report on drug facility inspections: FDA is directed to issue a report on its website annually on drug facility inspections, with a specific emphasis on pre-approval inspection timelines. The report must be published within 120 days of each new fiscal year.

January 29, 2024

Regulatory actions FDA expected to take place in December and January

This list, based on the federal government’s Unified Agenda, contains all the regulations that FDA has said it intends 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.

Regulation Title

FDA Description of the Rule

Action Planned (Or Originally Planned)

Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (Final Rule)

This regulation would permit an Institutional Review Board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent under limited conditions, for certain minimal risk clinical investigations. This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies. This regulation is intended to aid patient access to new products by facilitating investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions, including products that may address unmet medical needs.

November 2023

(Under OIRA Review)

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)

Compounded drug products must satisfy the conditions of section 503A or section 503B of the FD&C Act to qualify for certain statutory exemptions listed under each section. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding. FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B. Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists.

October 2023

(Under OIRA Review)

Post Approval Changes to Approved Applications (Proposed Rule)

The proposed rule would update the existing regulations governing supplements and other changes to approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as regulations regarding certain post-approval reports.

December 2023

Clinical Holds in Medical Device Investigations (Proposed Rule)

The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. The proposed rule would implement section 520(g)(8) of the Federal Food, Drug, and Cosmetic Act authorizing clinical holds for device investigations.

December 2023

Contact Lens Devices; Designation of Special Controls for Daily Wear Contact Lenses (Proposed Rule)

FDA is proposing in this rulemaking to designate special controls for daily wear contact lenses in order to address by regulation our current understanding of the risks to health for these devices, which were originally reclassified from class III (premarket approval) into class II (special controls) in 1994. The proposed special controls will reflect the Agency’s current guidance and review practice for daily wear contact lenses.

December 2023

Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior (Proposed Rule)

The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA finalized a ban on these devices in 2020, but the D.C. Circuit vacated the final rule in 2021. FDA previously determined that the use of ESDs for SIB and AB presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling. Now that Congress has removed the statutory basis for the D.C. Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices.

December 2023

Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule)

The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs. Current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug’s claimed effects. The final rule harmonizes the combination drug requirements into a single set of regulations for both prescription and nonprescription combination drugs and codifies existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The final rule also applies these regulations to combinations of biological drug products and to drug-biological product combinations; clarifies application of FDA’s requirements regarding fixed combinations to certain natural source drugs and certain synthetic drugs; establishes circumstances under which the Agency might waive the combination requirements for a particular drug or biological product; and addresses the issue of co-packaging.

December 2023

General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products (Final Rule)

This rule will apply device restrictions to sunlamp products. Sunlamp products include ultraviolet (UV) lamps and UV tanning beds and booths. The incidence of skin cancer, including melanoma, has been increasing, and a large number of skin cancer cases are attributable to the use of sunlamp products. The devices may cause about 400,000 cases of skin cancer per year, and 6,000 of which are melanoma. Beginning use of sunlamp products at young ages, as well as frequently using sunlamp products, both increases the risk of developing skin cancers and other illnesses, and sustaining other injuries. Even infrequent use, particularly at younger ages, can significantly increase these risks.

December 2023

Medical Devices; Quality System Regulation Amendments (Final Rule)

FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.

December 2023

Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests (Final Rule)

FDA intends to issue a final rule to classify Human Leukocyte Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil Antigen (HNA) devices into class II (special controls). FDA is also identifying special controls for HLA, HPA, and HNA devices that are necessary to provide a reasonable assurance of safety and effectiveness. The final rule takes into account the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices.

December 2023

Amendment to Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications (Final Rule)

FDA is proposing to amend the Adverse Event Reporting regulations for marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application. The proposed amendment will provide clarity to industry regarding when adverse event reports must be submitted to the Agency.

January 2024

Color Additive Certification; Increase in Fees for Certification Services (Final Rule)

The Food and Drug Administration (FDA) is proposing to amend the color additive regulation to increase the fees for certification services. The change in fees will allow FDA to maintain an adequate color certification program as required by section 721(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379e(e)).

January 2024

Amendments to Patent Term Restoration (Proposed Rule)

FDA is proposing to amend its Patent Term Restoration regulations to identify the effective date of approval for scheduled drugs, to define when the 60-day period referred to in 35 U.S.C. 156(d)(1) begins, to define the term business day for purposes of patent term extension, and to explain how approvals transmitted after 4:30 p.m. fit in this definition. The proposed amendments will update FDA regulations to incorporate the statutory amendments. Other proposed changes to the regulations will make them conform with existing practices.

January 2024

Regulatory actions that are overdue for release as of December

The FDA often misses its self-imposed deadlines for releasing specific regulations on its Unified Agenda. These are the regulations that the agency has said would be released by now, but have yet to be published (and are not under OIRA review).

Regulation Title

FDA Description of the Rule

Action Planned

Recalls of Products Subject to the Jurisdiction of the Food and Drug Administration

(Pre-Rule)

The Food and Drug Administration (FDA or the Agency) is issuing an advance notice of proposed rulemaking (ANPRM) to obtain information related to recalls of products subject to the jurisdiction of the FDA and to invite comments that may inform FDA’s intention to revise the Agency’s guidance on policy, procedures, and industry responsibilities for recalls (including product corrections) (FDA’s recall regulation). Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

June 2023

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

(Proposed Rule)

Human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). As a result, our statutory authority under section 704(a)(4) of the FD&C Act to request records or other information in advance of or in lieu of a drug establishment inspection does not apply to these products. This means that, currently, FDA can request that establishments submit records voluntarily in advance of or in lieu of an inspection for 361 HCT/Ps but cannot require that HCT/P establishments provide such records. Additionally, FDA currently relies on voluntary participation for remote interactive evaluations (such as remote livestreaming video of operations, teleconferences, and screen sharing) of establishments that manufacture 361 HCT/Ps.

The proposed amendment to the regulations at 21 CFR part 1271, subpart F would establish requirements for the submission of records or other information to FDA upon request, in advance of or in lieu of an inspection of establishments that manufacture 361 HCT/Ps and require the participation in a remote interactive evaluation of such establishments, upon request by FDA.

June 2023

Sunlamp Products; Amendment to the Performance Standard

(Final Rule)

FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards. By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources.

June 2023

Administrative Destruction of Certain Devices Refused Admission to the United States

(Final Rule)

Section 708 in the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, added FDA authority to section 801(a) of the FD&C Act to destroy any refused drug valued at $2500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. The final rule will amend the administrative destruction provisions in 21 CFR 1.94 to include devices.

June 2023

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.

June 2023

Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices (Final Rule)

FDA intends to issue a direct final rule and companion proposed rule that would make a minor amendment to 21 CFR part 807 to correct an inconsistency in FDA regulations governing registration and listing requirements that apply to human cells, tissues, or cellular or tissue-based products (HCT/Ps) regulated as devices. The amendment would make clear that the establishments that manufacture HCT/Ps regulated as devices are required to follow the registration and listing procedures in 21 CFR part 807. This proposed revision to 21 CFR 807 is for consistency with FDA’s current regulations under 21 CFR part 1271, subpart A.

June 2023

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

(Proposed Rule)

This proposed rule would amend the regulation regarding the list of drug products that were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective and may not be compounded under the exemptions provided by section 503A or section 503B of the Federal Food, Drug, and Cosmetic Act.

August 2023

Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Cream, or Ointment, and Liquid Wound Washes

(Proposed Rule)

FDA is proposing to classify the following three categories of unclassified, pre-amendments devices containing antimicrobials and/or other chemicals: certain solid wound dressings, wound dressings formulated as gels, creams, and ointments, and liquid wound washes, currently in product codes FRO, GER, MGP, MGQ, and EFQ.

September 2023

Biologics License Applications and Master Files

 

(Final Rule)

The final rule will codify that a biological product that was originally approved as an NDA under the FD&C Act can continue to reference a DMF for drug substance, drug substance intermediate, or drug product information after the application is deemed to be a license under the PHS Act. The final rule also codifies FDA’s existing practice that a BLA may not otherwise rely on a master file for information concerning a drug substance, a drug substance intermediate, or a drug product except in the investigational phase of the application under an investigational new drug application. The final rule also clarifies that the non-biological constituent part(s) of a combination product in a BLA may rely on any information in a master file.

September 2023

Amending Regulations That Require Multiple Copies Submissions

 

(Proposed Rule)

This proposed rule would amend FDA’s regulations to remove requirements for submission of multiple copies and replace them with the requirement for a single submission in electronic format. This action is being undertaken to revise regulations that required paper submission in duplicate, triplicate, etc.

October 2023

Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act

 

(Proposed Rule)

FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act, although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drug products (the 503A Bulks List). The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

October 2023

Amendments to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act

 

(Final Rule)

FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs (the 503A Bulks List). FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list. FDA has also identified bulk drug substances that FDA has considered and proposed not to include on the 503A Bulks List. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future rulemaking.

October 2023

Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act

(Proposed Rule)

The Food and Drug Administration is proposing rulemaking regarding statutory requirements under section 503A of the Federal Food, Drug, and Cosmetic Act for certain distributions of compounded human drug products. The proposed rule, if finalized, will include provisions regarding a standard memorandum of understanding (MOU) that describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the standard MOU in investigating complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. It will also, if finalized, include provisions regarding the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the standard MOU. The rule, will also, if finalized, address communication with State boards of pharmacy.

October 2023

Current Good Manufacturing Practice for Outsourcing Facilities (Proposed Rule)

This rule would set forth the minimum current good manufacturing practice (cGMP) requirements for human drug products compounded by an outsourcing facility.

November 2023

Medical Devices; Cardiovascular Devices; Classification of More Than Minimally Manipulated Allograft Heart Valves (Proposed Rule)

FDA is proposing to classify more than minimally manipulated (MMM) allograft heart valves (product code OHA) into class III. FDA believes that there is insufficient information to determine that general controls and special controls provide reasonable assurance of safety and effectiveness for this device. FDA is publishing this proposed rule after considering the recommendations of the Circulatory System Devices Panel, regarding the classification of MMM allograft heart valves. These devices are currently reviewed through the 510(k) process. As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014. The proposed rule is intended to benefit device recipients by reducing the risk of device-related complications and death.

November 2023

Registration of Commercial Importers of Drugs; Good Importing Practice (Proposed Rule)

This proposed rulemaking 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.

November 2023

Revision of Product Jurisdiction Regulations (Final Rule)

FDA is amending its regulation on classifying medical products as drugs, devices, biological products, or combination products (products composed of two or more different types of medical products, e.g., a drug and device) and on Center assignment and regulation of combination products, in two respects. First, it would remove a duplicative administrative appeals process for appealing product classification and assignment determinations, streamlining the process for appealing these determinations for product sponsors and FDA staff and making the process more efficient. Second, it would also enhance regulatory clarity and efficiency by removing a provision that might be interpreted inconsistently with new requirements under the 21st Century Cures Act, which addresses when combination products can be marketed under a single application for the complete combination product or under separate applications for each constituent part (e.g., the drug and device) of the combination product.

November 2023

“What ever happened to…”

Remember that thing that happened the other year – the one that left the internet buzzing and your colleagues talking? What ever happened to that thing? This tracker is our attempt to keep tabs on a few of the highest-profile things that happened where a response is (eventually) expected. (Are we missing something here? Be sure to let us know. This is far from a comprehensive list).

What

When it might happen

Additional details

FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed.

Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

FDA pushes to bring dietary supplements into regulatory compliance with a 180-day amnesty period

FDA’s response to a Citizen Petition from Hyman, Phelps & McNamara contending that personalized pharmacogenomic information is not a medical device or diagnostic, and therefore should not be subject to regulation as it is the practice of medicine.

Unknown. FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.” With FDA’s LDT rule under development, we wonder if HPM could receive a response soon.

The FDA’s effort to restrict the use of personalized genomics testing gets new challenge

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

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