Guidance for industry : listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers.

Bibliographic Details
Corporate Author:	Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs
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:	United States. > Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Drug approval > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS117075

Available Online