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# CVM Draft Guide on CMC Technical Section
- URL: https://www.fdaweb.com/cvm-draft-guide-on-cmc-technical-section/
- Published: 2024-09-16T12:00:00.000Z
- Updated: 2026-09-14T14:41:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157780

FDA has posted a CVM [draft guidance](https://www.fda.gov/media/153632/download?ref=fdaweb.com) entitled “Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies.” The document replaces a 2015 version made available 9/2015 entitled “Two-Phased Chemistry, Manufacturing and Controls Technical Sections.”

The revision provides recommendations for submitting individual components of the CMC technical section (e.g., a drug substance component, a drug product component, and a sterile process validation component for sterile drug products). It also includes additional strategies for sponsors to obtain CVM input on certain types of information prior to submission of the CMC technical section.