Prescription Drugs: FDA Has Met Most Performance Goals for Reviweing Application |
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Author:
| U.S. Government Accountability Office, |
ISBN: | 978-1-4912-9669-1 |
Publication Date: | Aug 2013 |
Publisher: | CreateSpace Independent Publishing Platform
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Book Format: | Paperback |
List Price: | USD $15.99 |
Book Description:
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Drug applications-including NDAs, BLAs, and efficacy supplements-are reviewed primarily by FDA's Center for Drug Evaluation and Research (CDER), with a smaller proportion reviewed by the Center for Biologics Evaluation and Research (CBER).
Drug applications-including NDAs, BLAs, and efficacy supplements-are reviewed primarily by FDA's Center for Drug Evaluation and Research (CDER), with a smaller proportion reviewed by the Center for Biologics Evaluation and Research (CBER).