Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA-Reference-Cited by-同舟云学术

Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA

Published:2008-01 Issue:1 Volume:42 Page:45-56
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Faden Laura B.,Kaitin Kenneth I.

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/10.1177/009286150804200108.pdf

Reference11 articles.

1. Healy EM, Kaitin KI. The European Agency for the Evaluation of Medicinal Product’s centralized procedure for product approval: current status. Drug Inf J. 1999;33(4):969–978.

2. U.S. Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses. Code of Federal Regulations, 21 CFR 314. Dec. 11, 1992. Amended at 64 FR 402, Jan. 5, 1999.

3. U.S. Orphan Drug Act. Pub L No. 97–414, 96 Stat 2049 (1983).

4. U.S, Prescription Drug User Fee Act of 1992. Pub L No. 102–571 (1992) pt 29, 21 USC 279, 106 Stat 4491.

5. U.S. Food and Drug Administration Modernization Act. Pub L No. 105–115 (1997 Nov. 21). 21 USC 355a. 111 Stat 2296.

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