Docket Number:
FDA-2018-D-3151
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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

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Food and Drug Administration
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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-3151.