Guidance for industry qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act.

Other Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format: Electronic
Language: English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1999]
Physical Description: 1 online resource (ii, 22 pages)
Subjects:
Online Access: https://purl.fdlp.gov/GPO/LPS119057
https://purl.fdlp.gov/GPO/LPS119057

CMU Gov Pub Electronic

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LocationCall Number: Status
CMU Gov Pub Electronic HE 20.4702:P 34/2 Available