Guidance for industry : changes to an approved NDA or ANDA, questions and answers.

Guidance for industry : changes to an approved NDA or ANDA, questions and answers.

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, [2001]
Subjects:
Drug approval > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS120723
Description
Item Description:"CMC."
"January 2001."
Electronic resource.
Physical Description:1 electronic resource (11 pages)