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FDA comment periods: Clinical

8 open comment periods and 1 upcoming effective dates tagged Clinical. Subscribe (iCal).

Open for comment

Closes	Document
closes in 9 days Oct 26, 2026	Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments Notice · published May 29, 2026 · FDA-2026-N-5057 Clinical
closes in 27 days Nov 13, 2026	Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments Notice · published Sep 15, 2026 · FDA-2026-N-10165 Clinical
closes in 34 days Nov 20, 2026	Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information Notice · published Oct 6, 2026 · FDA-2026-N-10429 Clinical
closes in 44 days Nov 30, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards Notice · published Sep 29, 2026 · FDA-2026-N-10132 Clinical Medical devices
closes in 51 days Dec 7, 2026	Nonclinical Testing Terminology Proposed Rule · published Sep 22, 2026 · FDA-2026-N-5347 Clinical Vaccines / biologics
closes in 51 days Dec 7, 2026	Nonclinical Testing Terminology Rule · published Sep 22, 2026 · FDA-2026-N-5347 Clinical Vaccines / biologics
closes in 55 days Dec 11, 2026	Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments Notice · published Oct 16, 2026 · FDA-2026-N-12214 Clinical
closes in 75 days Dec 31, 2026	FDA Rare Disease Innovation Hub Future Programming; Request for Comments Notice · published Jan 30, 2026 · FDA-2026-N-0131 Clinical

Upcoming effective dates

Effective	Document
effective in 110 days Feb 4, 2027	Nonclinical Testing Terminology Rule · published Sep 22, 2026 · FDA-2026-N-5347 Clinical Vaccines / biologics

Recently closed

Closes	Document
closed 15 days ago Oct 2, 2026	Modification of Certain Terminology in Title 21; Reopening of the Comment Period Proposed Rule · published Aug 3, 2026 · FDA-2026-N-2886 Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco
closed 25 days ago Sep 22, 2026	Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability Notice · published Jun 24, 2026 · FDA-2019-D-4964 Clinical Vaccines / biologics
closed 31 days ago Sep 16, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements Notice · published Aug 17, 2026 · FDA-2026-N-1736 Clinical
closed 54 days ago Aug 24, 2026	Expedited Investigational New Drug Pilot Program; Request for Information; Extension of the Comment Period Notice · published Jul 21, 2026 · FDA-2026-N-4699 Clinical
closed 87 days ago Jul 22, 2026	Expedited Investigational New Drug Pilot Program; Request for Information Notice · published Jun 24, 2026 · FDA-2026-N-4699 Clinical
closed 95 days ago Jul 14, 2026	Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability Notice · published Apr 15, 2026 · FDA-2026-D-1255 Clinical Vaccines / biologics
closed 103 days ago Jul 6, 2026	Modification of Certain Terminology in Title 21 Proposed Rule · published May 6, 2026 · FDA-2026-N-2886 Clinical Vaccines / biologics Medical devices Food & dietary supplements Tobacco
closed 110 days ago Jun 29, 2026	AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period Notice · published May 28, 2026 · FDA-2026-N-4390 Clinical
closed 138 days ago Jun 1, 2026	Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments Notice · published Mar 31, 2026 · FDA-2026-N-2476 Clinical Vaccines / biologics
closed 141 days ago May 29, 2026	AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information Notice · published Apr 29, 2026 · FDA-2026-N-4390 Clinical
closed 152 days ago May 18, 2026	General Considerations for the Use of New Approach Methodologies in Drug Development; Draft Guidance for Industry; Availability Notice · published Mar 19, 2026 · FDA-2025-D-6131 Clinical
closed 158 days ago May 12, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements Notice · published Mar 13, 2026 · FDA-2026-N-1736 Clinical
closed 166 days ago May 4, 2026	New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Notice · published Mar 4, 2026 · FDA-2024-D-4388 Clinical

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