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Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.

Bibliographic Details
Corporate Author: Center for Drug Evaluation and Research (U.S.)
Format: Government Document eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004]
Subjects:
Drug approval > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS120724
Description
Item Description:"CMC."
"November 2004."
Electronic resource.
Physical Description:1 online resource (2 pages)