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# CDER Commits to 11 Drug Quality Guides in 2025
- URL: https://www.fdaweb.com/cder-commits-to-11-drug-quality-guides-in-2025/
- Published: 2025-01-17T12:00:00.000Z
- Updated: 2026-09-14T14:51:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158511

A new [CDER guidance agenda](https://www.fda.gov/media/185228/download?attachment&ref=fdaweb.com) shows that the Center is committing to issuing 11 drug quality guidance documents in 2025\. Under GMP pharmaceutical quality, the agenda says the following four documents will be published:

- Approaches to Meeting CGMP Requirements for Distributed Manufacturing
- Laboratory Testing of Drugs Held in Interstate Commerce: Compliance with CGMP
- PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft
- Responding to Form FDA 483 Observations at the Conclusion of a Drug CGMP Inspection

Under chemistry, manufacturing and controls drug quality, the following seven documents are expected to be published:

- ANDAs: Stability Testing of Drug Substances and Products Q & A
- Container Closure Systems for Drugs, Including Biological Products
- Stability Considerations for Drug Substances and Drug Products in NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products
- Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs
- Guidelines for Establishing Impurity Limits for Antibiotics
- Current Good Manufacturing Practice for Medical Gases; Revised Draft
- Certification Process for Designated Medical Gases; Revised Draft

Additionally, regarding drug safety, CDER says it will publish a revised draft guidance on “Development of a Shared System or Separate REMS” and a final guidance entitled “REMS Logic Model: A Framework to Link Program Design with Assessment.”