505(b)(2) Applications: History, Science, and Experience-Reference-Cited by-同舟云学术

505(b)(2) Applications: History, Science, and Experience

Published:2002-04 Issue:2 Volume:36 Page:319-323
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Johnston Gordon,Williams Roger 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/10.1177/009286150203600210.pdf

Reference7 articles.

1. 21 U.S.C. 355(b)(2).

2. Sasinowski FJ, Scarlett T. Reliance on phantom ANDAs to access NDA data. Reg Affairs. 1991;3:467–482.

3. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance: Applications Covered by Section 505(b)(2). Rockville, MD: US Food and Drug Administration, Center for Drug Evaluation and Research: October 1999. http://www.fda.gov/cder/guidance/2853dft.htm.

4. FDA Public Docket No. 99D-4809, Pharmaceutical Research and Manufacturers of America, April 3, 2000.

5. Morgan, Lewis & Bockius Citizen Petition, FDA’s Docket Management Branch, July 27, 2001.

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