A Primer on CBER’s Regulatory Review Structure and Process-Reference-Cited by-同舟云学术

A Primer on CBER’s Regulatory Review Structure and Process

Published:1998-10 Issue:4 Volume:32 Page:1011-1030
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Sensabaugh Suzanne M.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)

Link

http://link.springer.com/content/pdf/10.1177/009286159803200422.pdf

Reference19 articles.

1. CBER Vision: 2004, Center for Biologics Evaluation and Research Strategic Plan for 2004. Rockville, MD: Food and Drug Administration; August 14, 1995.

2. Prescription Drug User Fee Act of 1992. Pub law 102-571 (1992 Oct 29); 21 USC 379; 106 Stat 4491.

3. Food and Drug Administration Modernization Act of 1997. Pub law 105-115 (1997 Nov 21).

4. The Food and Drug Administration Staff Manual Guides, Volume 1, Organizational Policy and Procedures. Rockville, MD: Food and Drug Administration; 1995.

5. Zoon KC. Presentation to the BIO Board. March 4, 1998; San Francisco, CA.

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