Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals-Reference-Cited by-同舟云学术

Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals

Published:2000-07 Issue:3 Volume:34 Page:919-959
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Zeid Robert L.

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/10.1177/009286150003400328.pdf

Reference44 articles.

1. Public Health Service Act (42 U.S.C. 262).

2. Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).

3. Drug Price Competition Act and Patent Term Restoration Act of 1984.

4. Food and Drug Administration Modernization Act (FDAMA) of 1997.

5. CBER. Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology. Rockville, MD: U.S. Food and Drug Administration; April 1985.

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