U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Postapproval Changes to Drug Substances Guidance for Industry
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Postapproval Changes to Drug Substances Guidance for Industry Draft Guidance for Industry September 2018

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research
Office of Foods and Veterinary Medicine, Center for Veterinary Medicine

This guidance provides recommendations to holders of approved new drug applications (NDAs), 16 abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and 17 abbreviated new animal drug applications (ANADAs) and holders of drug master files (DMFs) 18 and veterinary master files (VMFs) who want to make a change to the drug substance 19 manufacturing process during the drug product application’s postapproval period.2 It does not 20 address holders of biologics license applications (BLAs) or holders of any master files cross-21 referenced in BLAs.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.