Pharmaceutical provisions of the FDA Modernization Act of 1997: One year and counting

Current Opinion in Biotechnology

Volumn 10, Issue 3, 1999, Pages 303-306

  Binder, Gordon M ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; PHARMACEUTICS; POLICY; PRIORITY JOURNAL; PUBLIC HEALTH; SHORT SURVEY;

EID: 0033153164     PISSN: 09581669     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0958-1669(99)80054-8     Document Type: Article

References (6)

1. FDA's FDAMA Implementation Chart on World Wide Web URL: http://www.fda.gov/po/modact97.html
2. The US industry's input to the implementation effort is available at the website of the Pharmaceutical Research and Manufacturer's of America (PhRMA) on World Wide Web URL: http://www.phrma.org/issues/fda/fda.html
3. FDA report on new health care products approved in 1998. FDA Talk Paper, Jan 15, 1999.
4. The final rule was published at 63 Federal Register 64,555.
5. Civil Action no. 1:94CV01306 (D. D.C. July 30, 1998).
6. FDA Awaiting Market Experience to Issue Pharmacoeconomic Reg - Schultz. The Pink Sheet, (F-D-C Reports, October 12, 1998) at 4.