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# Guide on CMC Info for Gene Therapy Products
- URL: https://www.fdaweb.com/guide-on-cmc-info-for-gene-therapy-products/
- Published: 2018-07-12T12:00:00.000Z
- Updated: 2026-09-15T00:19:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141853

*Federal Register* notice: FDA has made available a draft guidance entitled “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).” The document provides sponsors of a human gene therapy IND with recommendations about CMC information required to assure product safety, identity, quality, purity, and strength (including potency) of the investigational product. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-12/pdf/2018-14866.pdf?ref=fdaweb.com).