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

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 |
|
Promotional Labeling and Advertising Considerations for Prescription Biological Reference, Biosimilar, and Interchangeable Products – Questions and Answers |
CBER |
Revision or Final |
12/24/2025 |
|
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers |
CBER |
Revision or Final |
3/23/2026 |
|
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 |
|
Collection of Platelets by Automated Methods; Draft Guidance for Industry |
CBER |
Draft |
CY2025 |
|
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry |
CBER |
Draft |
CY2025 |
|
Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry |
CBER |
Draft |
CY2025 |
|
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 |
|
Frequently Asked Questions — Cell and Gene Therapy Products; Guidance for Industry |
CBER |
Final |
CY2025 |
|
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 |
|
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Guidance for Industry |
CBER |
FInal |
CY2025 |
|
Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry |
CBER |
Final |
CY2025 |
|
Accelerated Approval of Human Gene Therapy Products for Rare Diseases; Draft Guidance for Industry |
CBER |
Draft |
CY2025 |
|
Use of Platform Technologies in Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry |
CBER |
Draft |
CY2025 |
|
Potency Assessment of Therapeutic Vaccines; Draft Guidance for Industry |
CBER |
Draft |
CY2025 |
|
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 |
|
Recommendations for Validation and Implementation of Alternative Microbial Methods for Testing of Biologics, Draft Guidance for Industry |
CBER |
Draft |
CY2025 |
|
Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements |
CDER |
Draft |
CY2025 |
|
Exclusivity for First Interchangeable Biosimilar Biological Products |
CDER |
Draft |
CY2025 |
|
NDC Creation, Assignment, Listing and Appropriate Use for Human Drugs, Including Biological Products |
CDER |
Draft |
CY2025 |
|
Priority Review Voucher Programs |
CDER |
Draft |
CY2025 |
|
Qualified Infectious Disease Product Designation—Questions and Answers |
CDER |
Revised Draft |
CY2025 |
|
Repackaging and Relabeling of Human Drugs: Labeling; Registration and Listing, Safety Reporting, Supply Chain Security, and Good Manufacturing Practice |
CDER |
Draft |
CY2025 |
|
Pediatric Study Plans for Biosimilar Products |
CDER |
Draft |
CY2025 |
|
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product |
CDER |
Revised Draft |
CY2025 |
|
Informative Bayesian Methods in Pediatric Clinical Trials |
CDER |
Draft |
CY2025 |
|
Master Protocols for Drug and Biological Product Development |
CDER |
Revised Draft |
CY2025 |
|
Malaria: Developing Drugs for Treatment |
CDER |
Draft |
CY2025 |
|
Chronic Spontaneous Urticaria: Developing Drugs for Treatment |
CDER |
Draft |
CY2025 |
|
Considerations for the Inclusion of Older Adults in Clinical Trials |
CDER |
Draft |
CY2025 |
|
Development of Animal-Derived Thyroid Products |
CDER |
Draft |
CY2025 |
|
Development of Non-Opioid Analgesics for Chronic Pain |
CDER |
Draft |
CY2025 |
|
Drugs With Teratogenic Potential-Recommendations for Pregnancy Planning and Prevention |
CDER |
Draft |
CY2025 |
|
Endometriosis-Associated Pain: Establishing Effectiveness and Safety of Drugs for Management |
CDER |
Draft |
CY2025 |
|
Enforcement Policy – Animal-Derived Thyroid Products Marketed Without an Approved Biologics License Application |
CDER |
Draft |
CY2025 |
|
Erosive Esophagitis: Developing Drugs for Treatment |
CDER |
Draft |
CY2025 |
|
Information To Submit To Support the Adequacy of Safety Evaluation Planning |
CDER |
Draft |
CY2025 |
|
Radiation Dosimetry for First-in-Human Studies of Positron Emission Tomography Drugs |
CDER |
Draft |
CY2025 |
|
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations |
CDER |
Revised Draft |
CY2025 |
|
Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment |
CDER |
Draft |
CY2025 |
|
Clinical Drug Interaction Studies With Combined Oral Contraceptives |
CDER |
Draft |
CY2025 |
|
Clinical Pharmacogenomics: Evaluation, Study Design, and Analysis |
CDER |
Draft |
CY2025 |
|
Pharmacokinetics in Patients with Impaired Hepatic Function – Study Design, Data Analysis, and Impact on Dosing and Labeling |
CDER |
Revised Draft |
CY2025 |
|
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling |
CDER |
Revised Draft |
CY2025 |
|
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 |
|
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 |
|
Compounding Under Section 503B of the Federal Food, Drug and Cosmetic Act and Considerations for Related to Drug Shortages |
CDER |
Draft |
CY2025 |
|
Nomination of Bulk Drug Substances for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act |
CDER |
Draft |
CY2025 |
|
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act |
CDER |
Revised Draft |
CY2025 |
|
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug and Cosmetic Act |
CDER |
Revised Draft |
CY2025 |
|
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 |
|
Development of a Shared System or Separate REMS |
CDER |
Revised Draft |
CY2025 |
|
180-Day Exclusivity: Questions and Answers |
CDER |
Revised Draft |
CY2025 |
|
30-Month Stay of Approval of an ANDA or 505(b)(2) Application |
CDER |
Draft |
CY2025 |
|
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin |
CDER |
Draft |
CY2025 |
|
ANDA Submissions — Content and Format Guidance for Industry |
CDER |
Draft |
CY2025 |
|
ANDA Submissions-Refuse-to-Receive for DMF Facilities Deficiencies |
CDER |
Draft |
CY2025 |
|
ANDA Submissions-Refuse-to-Receive for DMF Facilities Deficiencies |
CDER |
Draft |
CY2025 |
|
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs; Revised Draft |
CDER |
Revised Draft |
CY2025 |
|
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications |
CDER |
Revised Draft |
CY2025 |
|
Bioavailability and Bioequivalence Studies for Nasal Products |
CDER |
Draft |
CY2025 |
|
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application |
CDER |
Revised Draft |
CY2025 |
|
Certain Post-Approval Requirements and Resources for ANDAs |
CDER |
Draft |
CY2025 |
|
Considerations For Other Design Differences Identified in Comparative Analyses for a Drug-Device Combination Product Submitted in an ANDA |
CDER |
Draft |
CY2025 |
|
Determining Whether to Submit an ANDA or 505(b)(2) Application |
CDER |
Draft |
CY2025 |
|
Forms FDA 3542a and FDA 3542: Questions and Answers |
CDER |
Draft |
CY2025 |
|
Handling and Retention of BA and BE Testing Samples |
CDER |
Revised Draft |
CY2025 |
|
In Vitro Permeation Tests for Semisolid Topical Products Submitted in ANDAs |
CDER |
Revised Draft |
CY2025 |
|
In Vitro Release Tests for Semisolid Topical Products Submitted in ANDAs |
CDER |
Revised Draft |
CY2025 |
|
Mechanistic Modeling and Simulation Approaches to Assess Local and Systemic Bioavailability and Bioequivalence for Non-Orally Administered Drug Products |
CDER |
Draft |
CY2025 |
|
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers |
CDER |
Draft |
CY2025 |
|
“Open for Business” Under 744B of the Federal Food, Drug and Cosmetic Act |
CDER |
Draft |
CY2025 |
|
Submission of Patent Information for Listing in the Orange Book: Questions and Answers |
CDER |
Draft |
CY2025 |
|
Pediatric Exclusivity General Considerations for ANDAs |
CDER |
Draft |
CY2025 |
|
Product-Specific Guidances for Generic Drug Development |
CDER |
Draft |
CY2025 |
|
Use of a Type V Drug Master File for Model Master File Submissions |
CDER |
Draft |
CY2025 |
|
M13C Bioequivalence for Immediate-Release Solid Oral Dosage Forms; Advanced Bioequivalence Study Design and Data Analysis Considerations |
CDER/ICH |
Draft/Step 2 |
CY2025 |
|
Clinical Pharmacogenomics Information in Human Prescription Drug and Biological Product Labeling |
CDER |
Draft |
CY2025 |
|
Combined Hormonal Contraceptives for Prevention of Pregnancy-Labeling for Health Care Providers and Patients |
CDER |
Draft |
CY2025 |
|
Impact of Identifying Group Purchasing Organizations on a Drug Label |
CDER |
Draft |
CY2025 |
|
Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs |
CDER |
Draft |
CY2025 |
|
Approaches to Meeting CGMP Requirements for Distributed Manufacturing |
CDER |
Draft |
CY2025 |
|
Laboratory Testing of Drugs Held in Interstate Commerce: Compliance with CGMP |
CDER |
Draft |
CY2025 |
|
PET Drugs – Current Good Manufacturing Practice (CGMP) |
CDER |
Revised Draft |
CY2025 |
|
Responding to Form FDA 483 Observations at the Conclusion of a Drug CGMP |
CDER |
Draft |
CY2025 |
|
ANDAs: Stability Testing of Drug Substances and Products Q & A |
CDER |
Draft |
CY2025 |
|
Container Closure Systems for Drugs, Including Biological Products |
CDER |
Draft |
CY2025 |
|
Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs |
CDER |
Draft |
CY2025 |
|
Guidelines for Establishing Impurity Limits for Antibiotics |
CDER |
Draft |
CY2025 |
|
Current Good Manufacturing Practice for Medical Gases |
CDER |
Revised Draft |
CY2025 |
|
Certification Process for Designated Medical Gases |
CDER |
Revised Draft |
CY2025 |
|
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency |
CDRH |
Final |
FY2025 |
|
Enforcement Discretion Policy for Certain Laboratory Developed Tests for Unmet Needs: Frequently Asked Question |
CDRH |
Draft |
FY2025 |
|
Enforcement Discretion Policy for Premarket and Other Requirements for NIOSH-Approved Air Purifying Respirators |
CDRH |
Draft |
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 |
|
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 |
|
In Vitro Diagnostics: Labeling |
CDRH |
Draft |
FY2025 |
|
Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls |
CDRH |
Final |
FY2025 |
|
Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act |
CDRH |
Final |
FY2025 |
|
Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (revision) |
CDRH |
Draft |
FY2025 |
|
Registration Fee Waiver for Certain Small Businesses Undergoing Financial Hardship |
CDRH |
Final |
FY2025 |
|
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision) |
CDRH |
Final |
FY2025 |
|
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision) |
CDRH |
Final |
FY2025 |
|
Computer Software Assurance for Production and Quality System Software |
CDRH |
Final |
FY2025 |
|
Policy for Regulatory Status of Device Software Functions (revision of Policy for Device Software Functions and Mobile Medical Applications) |
CDRH |
Draft |
FY2025 |
|
3D Printing Medical Devices at the Point of Care |
CDRH |
Draft |
FY2025 |
|
Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission |
CDRH |
Final |
FY2025 |
|
Clinical Evidence Considerations for Digital Mental Health Treatment Devices, including Computerized Behavioral Therapy Devices |
CDRH |
Draft |
FY2025 |
|
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (revision) |
CDRH |
Final |
FY2025 |
|
Evidentiary Expectations for 510(k) Implant Devices |
CDRH |
Final |
FY2025 |
|
General/Specific Intended Use (revision) |
CDRH |
Draft |
FY2025 |
|
Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations |
CDRH |
Final |
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 |
|
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions |
CDRH |
Final |
FY2025 |
|
Substantial Equivalence with Limitations: 510(k) Devices (revision of “Determination of Intended Use for 510(k) Devices”) |
CDRH |
Draft |
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 |
|
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 |
|
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) |
|
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 |
|
Accelerated Approval – Expedited Program for Serious Conditions |
CDER |
Final |
3/6/2026 |
|
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway |
CDER |
Final |
2/4/2026 |
|
Disseminated Coccidioidomycosis: Developing Drugs for Treatment |
CDER |
Draft |
12/29/2025 |
|
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies |
OCE |
Final |
6/26/2025 |
|
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) |
|
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) |
|
Processes and Practices Applicable to Bioresearch Monitoring Inspections |
ORA, OCP, CBER, CDER, CDRH, CFSAN, CTP, CVM |
Final |
8/3/2025 |
|
E20 Adaptive Clinical Trials |
CDER/ICH |
Draft/Step 2 |
April 2026 |
|
E21 Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials |
CDER/ICH |
Draft/Step 2 |
Q2 2025 |
|
E22 General Considerations for Patient Preference Studies |
CDER/ICH |
Draft/Step 2 |
Dec. 2025 |
|
M4Q(R2) Addressing Common Technical Document (CTD) Quality-Related Questions |
CDER/ICH |
Draft/Step 2 |
June 2025 |
|
M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP) Revised Draft Technical Specification |
CDER/ICH |
Draft/Step 2 |
CY2025 |
|
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms; Biowaiver Considerations for Additional Strengths |
CDER/ICH |
Draft/Step 2 |
Jan. 2025 |
|
Q1/Q5C Targeted Revisions of ICH Stability Guidelines |
CDER/ICH |
Draft/Step 2 |
Jan. 2025 |
|
Q3C(R10) Maintenance of the Guideline for Residual Solvents |
CDER/ICH |
Draft/Step 2 |
Sept. 2025 |
|
Q3E Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics |
CDER/ICH |
Draft/Step 2 |
June 2025 |
|
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports |
ICH |
Final/Step 4 |
May 2025 |
|
E6(R3) Good Clinical Practice |
ICH |
Final/Step 4 (Annex 2) |
June 2025 |
|
E14/S7B Questions and Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential |
ICH |
Final/Step 4 |
Nov. 2025 |
|
M11 Clinical Electronic Structured Harmonised Protocol |
ICH |
Final/Step 4 |
Nov. 2025 |
|
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 |
|
M15 General Principles for Model-Informed Drug Development |
ICH |
Final/Step 4 |
Q4 2025 |
|
Development of Cancer Drugs for Use in Multiple Phases of Treatment – Determining the Contribution of Each Phase to Overall Effect |
OCE |
Draft |
CY2025 |
|
Development of Cancer Drugs for Use in Novel Combination – Determining the Contribution of the Individual Drugs’ Effects |
OCE |
Draft |
CY2025 |
|
Approaches to Assessment of Overall Survival in Oncology Clinical Trials |
OCE |
Draft |
CY2025 |
|
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development |
OCE |
Draft |
CY2025 |
|
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Revision) |
OCE |
Revision |
CY2025 |
|
Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment |
OCE |
Draft |
CY2025 |
|
Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval |
OCE |
Draft |
CY2025 |
|
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Research under 21 CFR 50.22 |
OCMO |
Draft |
CY2025 |
|
Unique Device Identifier (UDI) Requirements for Combination Products |
OCMO |
Draft |
CY2025 |
|
Choosing the Appropriate Center for a Master File Submission |
OCMO |
Draft |
CY2025 |
|
Labeling for Infusion Pumps that Deliver Subcutaneous Insulin |
OCMO |
Draft |
CY2025 |
|
How to Prepare a Pre-Request for Designation (Pre-RFD) |
OCMO |
Final |
CY2025 |
|
Formatting and Assembling Requests for Orphan Drug Designation |
OCMO |
Draft |
CY2025 |
|
Overview of the Orphan Drug Designation Program |
OCMO |
Draft |
CY2025 |
|
Key Information and Facilitating Understanding in Informed Consent |
OCMO |
Final |
CY2026 or CY2027 |
|
Payment and Reimbursement to Research Participants |
OCMO |
Revision |
CY2026 or CY2027 |
|
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products |
OCMO |
Final |
CY2026 or CY2027 |
|
Submissions for Postapproval Modifications to a Combination Product |
OCMO |
Revision |
CY2026 or CY2027 |
|
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors |
OCMO |
Final |
CY2026 or CY2027 |
|
Ethical Considerations for Clinical Investigations of Medical Products Involving Children |
OCMO |
Final |
CY2026 or CY2027 |
|
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 |
|
Conflicts of Interest and Eligibility for Participation in FDA Advisory Committees |
OCS |
Revision |
CY2025 |
|
Appearance Concerns and Authorizations for Participation in FDA Advisory Committees |
OCS |
Revision or Final |
CY2025 |
|
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs |
CDER |
Final |
7/1/2023 (Overdue) |
|
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) |
|
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products |
CDER |
Draft |
FY2025 |
|
REMS Logic Model: A Framework to Link Program Design with Assessment |
CDER |
Revised Draft |
CY2025 |
|
Post Approval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry |
CBER |
Draft |
9/30/2025 |
|
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions |
CDER |
Revised Draft |
9/30/2025 |
|
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle |
CDER |
Revision or Final |
6/5/2026 |
|
Best Practices for Communication Between IND Sponsors and FDA During Drug Development |
CDER |
Revision (As appropriate) |
1/22/2026 |
|
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 |
|
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 |
|
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 |
|
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 |