The 176 guidance documents that FDA is currently working on affecting the life sciences industry

Life Sciences | By Amanda Conti

Jan. 29, 2025

What regulatory policies are under development at the FDA, and when might those policies be published? AgencyIQ has undertaken a comprehensive analysis of the agency’s various guidance agendas, user fee commitment letters, international harmonization efforts and legislative deadlines to provide a comprehensive list of 176 guidance documents that we know the agency is actively working on. While some policies are required to be published, others aren’t – and could be delayed by the incoming Trump administration. We have the key details for you below.

Background: Governing by guidance

  • Guidance documents are used to fill in the gaps of regulation by offering non-binding advice to companies on how the FDA intends to interpret or operationalize parts of regulations. For example, while federal law might require a company to submit “substantial evidence of effectiveness” to the FDA to obtain approval, the FDA could then issue a guidance document on how it interprets the phrase “substantial” in terms of the number of trials, the types of enrollees, and the design of the studies for a specific disease.
  • In late 2024, FDA issued a final report and plan to improve its processes for developing, publishing and publicizing guidance documents. This fulfilled a requirement in Section 2505 of the Food and Drug Omnibus Reform Act (FDORA), passed in late 2022 as part of a federal budget bill. Among other changes and clarifications, the report pledged to update the agency’s Good Guidance Practices (GGP) regulations. [ Read full AgencyIQ analysis here.].
  • GGP requires FDA to publish “a list of possible topics for future guidance document development or revision during the next year.” This list is known as a “guidance agenda,” which in practice details the documents that FDA plans to release to the public, not simply develop. However, the FDA does not publish a singular guidance agenda; rather, it publishes separate agendas from each major product review center (CBER, Center for Drug Evaluation and Research [CDER], Center for Devices and Radiological Health [CDRH], the former Center for Food Safety and Applied Nutrition [CFSAN], which has been subsumed into the Human Foods Program as part of the FDA’s reorganization, which took effect Oct. 1, 2024), as well as some additional FDA offices (like its Office of the Chief Scientist [OCS]). Starting in 2025, FDA has also released guidance agendas for its Office of the Chief Medical Officer (OCMO) and Oncology Center of Excellence (OCE).
  • There are other sources of guidance documents as well. In addition to the agency’s guidance agendas, Congress also requires the agency it to publish some guidance documents. Others are required by various FDA user fee programs, like the Prescription Drug User Fee program (PDUFA). Still others are developed as part of international regulatory harmonization initiatives like the International Council for Harmonization (ICH).

AgencyIQ’s combined guidance agenda

  • AgencyIQ has developed the following list of guidance documents under development or required to be published in the coming years. The following list contains document titles and descriptions from multiple sources, but three in particular: guidance agendas published by FDA centers, user fee commitment letters, and legislation. [See AgencyIQ’s detailed analyses on the CDRH FY2025 Guidance Agenda, CBER 2025 Guidance Agenda, and OCMO’s first agenda, as well as our regularly updated FDA Guidance Tracker resource.].
  • Some technical notes: While lengthy, this list is not completely comprehensive. For example, CDER’s 2025 Guidance Agenda is limited to new and revised draft documents and does not include guidance documents that it expects to finalize in 2025. Where possible, we’ve tried to be specific about the timeframes in which documents are expected or intended to be released. In some cases, FDA is technically required by federal law to release documents as of a certain date (although in practice, these dates are often missed). For example, statute may require that a guidance document is finalized within 18 months of the close of the comment period for the draft version. In other cases, such as the non-binding, aspirational guidance agendas, the FDA is under no obligation to release a document at any time. If a guidance is listed in multiple places (e.g., a guidance agenda and legislation), we have listed the more specific date.
  • Leadership and priority changes associated with the transition to the Presidency of DONALD TRUMP is also likely to inject substantial uncertainty into whether the documents listed below will ultimately see publication. The various FDA guidance agendas were all published in the waning days of the Biden administration, and new leaders at FDA may have different priorities. For example, the FDORA legislation directs FDA to finalize guidance implementing requirements for Diversity Action Plans by around June 2024. However, as AgencyIQ recently discussed, the draft version of the guidance (issued in June 2024, replacing a 2022 draft version) was quietly removed from the FDA’s guidance database as of Jan. 23, 2025, leaving its future uncertain. It may take some time to see changes, since FDA is currently affected by a federal agency-wide “regulatory freeze” as a result of an executive order.

Featuring previous research by Alexander Gaffney, Chelsey McIntyre, Kari Oakes, Laura DiAngelo, Amanda Conti and Kedest Tadesse.
To contact the author of this item, please email Amanda Conti ( aconti@agencyiq.com).To contact the editor of this item, please email Alexander Gaffney ( agaffney@agencyiq.com)

Life sciences guidance documents that FDA is currently working on:

Document Title or Description

Centers

Type

Intended Release

Source

Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts

CDER

Draft

FY2025

BsUFA III Commitment Letter

Promotional Labeling and Advertising Considerations for Prescription Biological Reference, Biosimilar, and Interchangeable Products – Questions and Answers

CBER

Revision or Final

12/24/2025

BsUFA III Commitment Letter

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers

CBER

Revision or Final

3/23/2026

BsUFA III Commitment Letter

Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method

CBER

Final

CY2025

CBER Guidance Agenda 2025

Collection of Platelets by Automated Methods; Draft Guidance for Industry

CBER

Draft

CY2025

CBER Guidance Agenda 2025

Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry

CBER

Draft

CY2025

CBER Guidance Agenda 2025

Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry

CBER

Draft

CY2025

CBER Guidance Agenda 2025

Recommendations for the Evaluation of Blood Collection, Processing, and Storage Devices Using Non-Di(2-ethylhexyl) Phthalate (non-DEHP) Materials: Draft Guidance for Industry

CBER

Draft

CY2025

CBER Guidance Agenda 2025

Frequently Asked Questions — Cell and Gene Therapy Products; Guidance for Industry

CBER

Final

CY2025

CBER Guidance Agenda 2025

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; Guidance for Industry

CBER

Final

CY2025

CBER Guidance Agenda 2025

Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Guidance for Industry

CBER

FInal

CY2025

CBER Guidance Agenda 2025

Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry

CBER

Final

CY2025

CBER Guidance Agenda 2025

Accelerated Approval of Human Gene Therapy Products for Rare Diseases; Draft Guidance for Industry

CBER

Draft

CY2025

CBER Guidance Agenda 2025

Use of Platform Technologies in Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry

CBER

Draft

CY2025

CBER Guidance Agenda 2025

Potency Assessment of Therapeutic Vaccines; Draft Guidance for Industry

CBER

Draft

CY2025

CBER Guidance Agenda 2025

Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions; Guidance for Industry

CBER

Final

CY2025

CBER Guidance Agenda 2025

Recommendations for Validation and Implementation of Alternative Microbial Methods for Testing of Biologics, Draft Guidance for Industry

CBER

Draft

CY2025

CBER Guidance Agenda 2025

Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Exclusivity for First Interchangeable Biosimilar Biological Products

CDER

Draft

CY2025

CDER Guidance Agenda 2025

NDC Creation, Assignment, Listing and Appropriate Use for Human Drugs, Including Biological Products

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Priority Review Voucher Programs

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Qualified Infectious Disease Product Designation—Questions and Answers

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Repackaging and Relabeling of Human Drugs: Labeling; Registration and Listing, Safety Reporting, Supply Chain Security, and Good Manufacturing Practice

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Pediatric Study Plans for Biosimilar Products

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Informative Bayesian Methods in Pediatric Clinical Trials

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Master Protocols for Drug and Biological Product Development

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Malaria: Developing Drugs for Treatment

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Chronic Spontaneous Urticaria: Developing Drugs for Treatment

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Considerations for the Inclusion of Older Adults in Clinical Trials

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Development of Animal-Derived Thyroid Products

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Development of Non-Opioid Analgesics for Chronic Pain

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Drugs With Teratogenic Potential-Recommendations for Pregnancy Planning and Prevention

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Endometriosis-Associated Pain: Establishing Effectiveness and Safety of Drugs for Management

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Enforcement Policy – Animal-Derived Thyroid Products Marketed Without an Approved Biologics License Application

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Erosive Esophagitis: Developing Drugs for Treatment

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Information To Submit To Support the Adequacy of Safety Evaluation Planning

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Radiation Dosimetry for First-in-Human Studies of Positron Emission Tomography Drugs

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Clinical Drug Interaction Studies With Combined Oral Contraceptives

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Clinical Pharmacogenomics: Evaluation, Study Design, and Analysis

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Pharmacokinetics in Patients with Impaired Hepatic Function – Study Design, Data Analysis, and Impact on Dosing and Labeling

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Compounding Under Section 503B of the Federal Food, Drug and Cosmetic Act and Considerations for Related to Drug Shortages

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug and Cosmetic Act

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors-Guidance for Outsourcing Facilities Under Section 503B of the FD&C Act

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Development of a Shared System or Separate REMS

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

180-Day Exclusivity: Questions and Answers

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

30-Month Stay of Approval of an ANDA or 505(b)(2) Application

CDER

Draft

CY2025

CDER Guidance Agenda 2025

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin

CDER

Draft

CY2025

CDER Guidance Agenda 2025

ANDA Submissions — Content and Format Guidance for Industry

CDER

Draft

CY2025

CDER Guidance Agenda 2025

ANDA Submissions-Refuse-to-Receive for DMF Facilities Deficiencies

CDER

Draft

CY2025

CDER Guidance Agenda 2025

ANDA Submissions-Refuse-to-Receive for DMF Facilities Deficiencies

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs; Revised Draft

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Bioavailability and Bioequivalence Studies for Nasal Products

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Certain Post-Approval Requirements and Resources for ANDAs

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Considerations For Other Design Differences Identified in Comparative Analyses for a Drug-Device Combination Product Submitted in an ANDA

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Determining Whether to Submit an ANDA or 505(b)(2) Application

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Forms FDA 3542a and FDA 3542: Questions and Answers

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Handling and Retention of BA and BE Testing Samples

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

In Vitro Permeation Tests for Semisolid Topical Products Submitted in ANDAs

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

In Vitro Release Tests for Semisolid Topical Products Submitted in ANDAs

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Mechanistic Modeling and Simulation Approaches to Assess Local and Systemic Bioavailability and Bioequivalence for Non-Orally Administered Drug Products

CDER

Draft

CY2025

CDER Guidance Agenda 2025

New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers

CDER

Draft

CY2025

CDER Guidance Agenda 2025

“Open for Business” Under 744B of the Federal Food, Drug and Cosmetic Act

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Submission of Patent Information for Listing in the Orange Book: Questions and Answers

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Pediatric Exclusivity General Considerations for ANDAs

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Product-Specific Guidances for Generic Drug Development

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Use of a Type V Drug Master File for Model Master File Submissions

CDER

Draft

CY2025

CDER Guidance Agenda 2025

M13C Bioequivalence for Immediate-Release Solid Oral Dosage Forms; Advanced Bioequivalence Study Design and Data Analysis Considerations

CDER/ICH

Draft/Step 2

CY2025

CDER Guidance Agenda 2025

Clinical Pharmacogenomics Information in Human Prescription Drug and Biological Product Labeling

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Combined Hormonal Contraceptives for Prevention of Pregnancy-Labeling for Health Care Providers and Patients

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Impact of Identifying Group Purchasing Organizations on a Drug Label

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Approaches to Meeting CGMP Requirements for Distributed Manufacturing

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Laboratory Testing of Drugs Held in Interstate Commerce: Compliance with CGMP

CDER

Draft

CY2025

CDER Guidance Agenda 2025

PET Drugs – Current Good Manufacturing Practice (CGMP)

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Responding to Form FDA 483 Observations at the Conclusion of a Drug CGMP

CDER

Draft

CY2025

CDER Guidance Agenda 2025

ANDAs: Stability Testing of Drug Substances and Products Q & A

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Container Closure Systems for Drugs, Including Biological Products

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Guidelines for Establishing Impurity Limits for Antibiotics

CDER

Draft

CY2025

CDER Guidance Agenda 2025

Current Good Manufacturing Practice for Medical Gases

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Certification Process for Designated Medical Gases

CDER

Revised Draft

CY2025

CDER Guidance Agenda 2025

Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Enforcement Discretion Policy for Certain Laboratory Developed Tests for Unmet Needs: Frequently Asked Question

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

Enforcement Discretion Policy for Premarket and Other Requirements for NIOSH-Approved Air Purifying Respirators

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies)

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

In Vitro Diagnostics: Labeling

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (revision)

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

Registration Fee Waiver for Certain Small Businesses Undergoing Financial Hardship

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision)

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Computer Software Assurance for Production and Quality System Software

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Policy for Regulatory Status of Device Software Functions (revision of Policy for Device Software Functions and Mobile Medical Applications)

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

3D Printing Medical Devices at the Point of Care

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

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

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Clinical Evidence Considerations for Digital Mental Health Treatment Devices, including Computerized Behavioral Therapy Devices

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (revision)

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Evidentiary Expectations for 510(k) Implant Devices

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

General/Specific Intended Use (revision)

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling (revision)

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

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

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

Substantial Equivalence with Limitations: 510(k) Devices (revision of “Determination of Intended Use for 510(k) Devices”)

CDRH

Draft

FY2025

CDRH Guidance Agenda FY2025

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff

CDRH

Final

FY2025

CDRH Guidance Agenda FY2025

FDA is directed to issue or update guidance on innovative approaches to drug design and manufacturing based on the Emerging Technology Program.

CDER

Draft

Not specified

FDORA 3203/566A

Stability Considerations for Drug Substances and Drug Products in NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products

CDER

Draft

12/29/2024 (Overdue)

FDORA Sec. 2512

FDA is directed to issue guidance on best practices for developing efficacy endpoints for rare disease drugs, including surrogate and intermediate endpoints as part of the Rare Disease Endpoint Advancement Pilot Program.

CDER

Draft

FY2027

FDORA Sec. 3208

Accelerated Approval – Expedited Program for Serious Conditions

CDER

Final

3/6/2026

FDORA Sec. 3210

Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway

CDER

Final

2/4/2026

FDORA Sec. 3210

Disseminated Coccidioidomycosis: Developing Drugs for Treatment

CDER

Draft

12/29/2025

FDORA Sec. 3211

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

OCE

Final

6/26/2025

FDORA Sec. 3602

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

CDER

Draft

12/29/23 (Overdue)

FDORA Sec. 3607

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.

CDRH

Draft

12/29/23 (Overdue)

FDORA Sec. 3611

Processes and Practices Applicable to Bioresearch Monitoring Inspections

ORA, OCP, CBER, CDER, CDRH, CFSAN, CTP, CVM

Final

8/3/2025

FDORA Sec. 3612

E20 Adaptive Clinical Trials

CDER/ICH

Draft/Step 2

April 2026

ICH 2025 Workplan

E21 Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

CDER/ICH

Draft/Step 2

Q2 2025

ICH 2025 Workplan

E22 General Considerations for Patient Preference Studies

CDER/ICH

Draft/Step 2

Dec. 2025

ICH 2025 Workplan

M4Q(R2) Addressing Common Technical Document (CTD) Quality-Related Questions

CDER/ICH

Draft/Step 2

June 2025

ICH 2025 Workplan

M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP) Revised Draft Technical Specification

CDER/ICH

Draft/Step 2

CY2025

ICH 2025 Workplan

M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms; Biowaiver Considerations for Additional Strengths

CDER/ICH

Draft/Step 2

Jan. 2025

ICH 2025 Workplan

Q1/Q5C Targeted Revisions of ICH Stability Guidelines

CDER/ICH

Draft/Step 2

Jan. 2025

ICH 2025 Workplan

Q3C(R10) Maintenance of the Guideline for Residual Solvents

CDER/ICH

Draft/Step 2

Sept. 2025

ICH 2025 Workplan

Q3E Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics

CDER/ICH

Draft/Step 2

June 2025

ICH 2025 Workplan

E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

ICH

Final/Step 4

May 2025

ICH 2025 Workplan

E6(R3) Good Clinical Practice

ICH

Final/Step 4 (Annex 2)

June 2025

ICH 2025 Workplan

E14/S7B Questions and Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential

ICH

Final/Step 4

Nov. 2025

ICH 2025 Workplan

M11 Clinical Electronic Structured Harmonised Protocol

ICH

Final/Step 4

Nov. 2025

ICH 2025 Workplan

M14 General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

ICH

Final/Step 4

June 2025

ICH 2025 Workplan

M15 General Principles for Model-Informed Drug Development

ICH

Final/Step 4

Q4 2025

ICH 2025 Workplan

Development of Cancer Drugs for Use in Multiple Phases of Treatment – Determining the Contribution of Each Phase to Overall Effect

OCE

Draft

CY2025

OCE Guidance Agenda 2025

Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects

OCE

Draft

CY2025

OCE Guidance Agenda 2025

Approaches to Assessment of Overall Survival in Oncology Clinical Trials

OCE

Draft

CY2025

OCE Guidance Agenda 2025

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

OCE

Draft

CY2025

OCE Guidance Agenda 2025

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Revision)

OCE

Revision

CY2025

OCE Guidance Agenda 2025

Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment

OCE

Draft

CY2025

OCE Guidance Agenda 2025

Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval

OCE

Draft

CY2025

OCE Guidance Agenda 2025

Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Research under 21 CFR 50.22

OCMO

Draft

CY2025

OCMO Guidance Agenda 2026-2027

Unique Device Identifier (UDI) Requirements for Combination Products

OCMO

Draft

CY2025

OCMO Guidance Agenda 2026-2027

Choosing the Appropriate Center for a Master File Submission

OCMO

Draft

CY2025

OCMO Guidance Agenda 2026-2027

Labeling for Infusion Pumps that Deliver Subcutaneous Insulin

OCMO

Draft

CY2025

OCMO Guidance Agenda 2026-2027

How to Prepare a Pre-Request for Designation (Pre-RFD)

OCMO

Final

CY2025

OCMO Guidance Agenda 2026-2027

Formatting and Assembling Requests for Orphan Drug Designation

OCMO

Draft

CY2025

OCMO Guidance Agenda 2026-2027

Overview of the Orphan Drug Designation Program

OCMO

Draft

CY2025

OCMO Guidance Agenda 2026-2027

Key Information and Facilitating Understanding in Informed Consent

OCMO

Final

CY2026 or CY2027

OCMO Guidance Agenda 2026-2027

Payment and Reimbursement to Research Participants

OCMO

Revision

CY2026 or CY2027

OCMO Guidance Agenda 2026-2027

Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

OCMO

Final

CY2026 or CY2027

OCMO Guidance Agenda 2026-2027

Submissions for Postapproval Modifications to a Combination Product

OCMO

Revision

CY2026 or CY2027

OCMO Guidance Agenda 2026-2027

Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors

OCMO

Final

CY2026 or CY2027

OCMO Guidance Agenda 2026-2027

Ethical Considerations for Clinical Investigations of Medical Products Involving Children

OCMO

Final

CY2026 or CY2027

OCMO Guidance Agenda 2026-2027

Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections

OCMO

Final

CY2026 or CY2027

OCMO Guidance Agenda 2026-2027

Conflicts of Interest and Eligibility for Participation in FDA Advisory Committees

OCS

Revision

CY2025

OCS Guidance Agenda

Appearance Concerns and Authorizations for Participation in FDA Advisory Committees

OCS

Revision or Final

CY2025

OCS Guidance Agenda

Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs

CDER

Final

7/1/2023 (Overdue)

OMUFA Commitment Letter

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act

CDER

Final

2/1/2024 (Overdue)

OMUFA Commitment Letter

Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

CDER

Draft

FY2025

PDUFA VII Commitment Letter

REMS Logic Model: A Framework to Link Program Design with Assessment

CDER

Revised Draft

CY2025

PDUFA VII Commitment Letter

Post Approval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry

CBER

Draft

9/30/2025

PDUFA VII Commitment Letter

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

CDER

Revised Draft

9/30/2025

PDUFA VII Commitment Letter

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

CDER

Revision or Final

6/5/2026

PDUFA VII Commitment Letter

Best Practices for Communication Between IND Sponsors and FDA During Drug Development

CDER

Revision (As appropriate)

1/22/2026

PDUFA VII Commitment Letter

FDA agreed to issue a draft guidance on how individual cell and gene therapy sponsors might leverage internal prior knowledge and public knowledge, including Chemistry, Manufacturing, and Controls, non-clinical, and clinical knowledge, across therapeutic contexts in order to facilitate product development and application review

CBER

Draft

FY2026

PDUFA VII Commitment Letter

FDA agreed to Issue a draft guidance on the evaluation of efficacy in small patient populations using novel trial designs and statistical methods, and how these concepts can be applied to more common diseases.

CDER, CBER

Draft

FY2025

PDUFA VII Commitment Letter

FDA agreed to publish additional draft guidances in identified areas of need related to Digital Health Technologies (DHT) informed by stakeholder engagement.

CDER, CBER

Draft

FY2027

PDUFA VII Commitment Letter

FDA agreed to enhance clarity and transparency for the NME Review Program by updating all relevant Manuals of Policies and Procedures (MAPPs), Standard Operating Procedures and Policies (SOPPs), and guidances regarding the pre-approval processes for establishing PMRs

CDER

TBD

FY2027

PDUFA VII Commitment Letter

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