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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.