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

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

Internet

https://purl.fdlp.gov/GPO/LPS120724

Available Online

Holdings details from Available Online
Call Number: HE 20.4702:N 42/3
 
Call Number Status Get It
HE 20.4702:N 42/3 Available