Faster Access to Drugs for Serious or Life-Threatening Illnesses Through use of the Accelerated Approval Regulation in the United States-Reference-Cited by-同舟云学术

Faster Access to Drugs for Serious or Life-Threatening Illnesses Through use of the Accelerated Approval Regulation in the United States

Published:1998-01 Issue:1 Volume:32 Page:27-35
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Cocchetto David M.,Jones Douglas R.

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/10.1177/009286159803200105.pdf

Reference25 articles.

1. Food and Drug Administration. Drug Administration. New Drug, Antibiotic, Biological Drug Product Regulations; Accelerated Approval. Proposed rule. Federal Register. April 15, 1992;57:13234–13242.

2. Food and Drug Administration. Drug Administration. New Drug, Antibiotic, Biological Drug Product Regulations; Accelerated Approval. Final rule. Federal Register. December 11, 1992;57:58942–58960.

3. Kessler DA. Issues in approving drugs for AIDS treatment. Regul Aff. 1994;6:189–200.

4. Kessler DA. Feiden KL. Faster evaluation of vital drugs. Scientif Am. March 1995;272 (No. 3):48–54.

5. Klein R. FDA s role in the treatment of HIV/AIDS. Regul Aff. 1994;6:221–227.

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