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