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FDA comment periods: CMC (chemistry, manufacturing & controls)

2 open comment periods and 0 upcoming effective dates tagged CMC (chemistry, manufacturing & controls). Subscribe (iCal).

Open for comment

Closes	Document
closes in 6 days Oct 23, 2026	Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice · published Aug 24, 2026 · FDA-2007-D-0369 CMC (chemistry, manufacturing & controls)
closes in 32 days Nov 18, 2026	Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability Notice · published Aug 20, 2026 · FDA-2026-D-8561 CMC (chemistry, manufacturing & controls) Vaccines / biologics

Upcoming effective dates

None upcoming.

Recently closed

Closes	Document
closed 4 days ago Oct 13, 2026	Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability Notice · published Aug 14, 2026 · FDA-2026-D-7957 CMC (chemistry, manufacturing & controls) Medical devices
closed 15 days ago Oct 2, 2026	Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability Notice · published Aug 3, 2026 · FDA-2026-D-4272 CMC (chemistry, manufacturing & controls) Vaccines / biologics Medical devices
closed 16 days ago Oct 1, 2026	Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation Schedule Notice · published Apr 6, 2026 · FDA-2016-D-1280 CMC (chemistry, manufacturing & controls) Vaccines / biologics
closed 19 days ago Sep 28, 2026	Product-Specific Guidances; Revised Draft Guidances for Industry; Availability Notice · published Jul 29, 2026 · FDA-2007-D-0369 CMC (chemistry, manufacturing & controls)
closed 88 days ago Jul 21, 2026	Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice · published May 22, 2026 · FDA-2007-D-0369 CMC (chemistry, manufacturing & controls)
closed 96 days ago Jul 13, 2026	Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period Notice · published Jun 11, 2026 · FDA-2026-N-0809 CMC (chemistry, manufacturing & controls)
closed 117 days ago Jun 22, 2026	Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability Notice · published Apr 20, 2026 · FDA-2025-D-6130 CMC (chemistry, manufacturing & controls)
closed 124 days ago Jun 15, 2026	International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1); Draft Guidance for Industry; Availability Notice · published Apr 16, 2026 · FDA-2021-D-0613 CMC (chemistry, manufacturing & controls) Food & dietary supplements
closed 138 days ago Jun 1, 2026	Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments Notice · published Mar 3, 2026 · FDA-2026-N-0809 CMC (chemistry, manufacturing & controls)
closed 172 days ago Apr 28, 2026	Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Notice · published Feb 27, 2026 · FDA-2007-D-0369 CMC (chemistry, manufacturing & controls)

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