FDAMA update

Food and Drug Law Journal

Volumn 54, Issue 1, 1999, Pages 21-33

  Suydam, Linda A ^a   Elder, David K ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BUDGET; FOOD AND DRUG ADMINISTRATION; INFORMATION SCIENCE; LAW; MANAGEMENT; RESPONSIBILITY; REVIEW; SCIENCE;

FORECASTING; HUMANS; ORGANIZATIONAL OBJECTIVES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032909035     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (24)

1. Pub. L. No. 105-115, 111 Stat. 2296.
2. See FDAMA Accomplishments One Year After Enactment, FDA Talk Paper No. T98-82 (Nov. 23, 1998).
3. See id. For more details, see 〈www.fda.gov/po/modact97.html〉.
4. See 〈www.randomjoke.com/topic/quotes.jhtml〉.
5. Funding history statistics compiled by the FDA Office of Financial Management.
6. Statistics in this table were compiled by the FDA Office of Financial Management.
7. Statistics in this table were compiled by the FDA Office of Financial Management.
8. Pub. L. No. 102-571, 106 Stat. 4491 (1992) (codified in scattered sections of 21 U.S.C. (1994)).
9. See 〈www.famous-quotes.com〉.
10. FDAMA § 406(b).
11. 63 Fed. Reg. 64,999 (Nov. 24, 1998).
12. The dates of these meetings and agency Centers involved were: Center for Food Safety and Applied Nutrition (CFSAN) (June 25, 1998); Center for Biologics Evaluation and Research (CBER) (Aug. 14, 1998, and Aug. 28, 1998); Center for Drug Evaluation and Research (CDER) (Aug. 17, 1998); Center for Devices and Radiological Health (CDRH) (Aug. 18, 1998); Center for Veterinary Medicine (CVM) (Aug. 19, 1998); Office of Health Affairs (OHA) (Sept. 8, 1998); and FDA (Sept. 14, 1998).
13. 63 Fed. Reg. 58,743 (Nov. 2, 1998).
14. See 〈www.fda.gov/cber/minutes/dev120198T.pdf〉.
15. See 〈www.shrike.depaul.edu〉.
16. The Food Safety Initiative was announced in an Executive Order (May 12, 1997). See also 〈www.foodafety.gov〉.
17. See 〈www.fda.gov〉.
18. FDAMA section 406(b) states: Mission. - The Administration shall -(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; (2) with respect to such products, protect the public health by ensuring that -(A) foods are safe, wholesome, sanitary, and properly labeled; (B) human and veterinary drugs are safe and effective; (C) there is reasonable assurance of the safety and effectiveness of devices intended for human use; (D) cosmetics are safe and properly labeled; and (E) public health and safety are protected from electronic product radiation; (3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and (4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products. 21 U.S.C § 393(b) (FDCA § 903(b)).
19. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified at 21 U.S.C. §§ 301 et seq. (1994)).
20. Import statistics compiled by FDA Operational and Administrative System for Import Support.
21. Compiled by the FDA Office of Planning and Evaluation.
22. Compiled by the FDA Office of Planning and Evaluation.
23. See 〈www.sivideo.com/quotes.htm〉.
24. See 〈www.fda.gov/opacom/fdamact〉.