FDA and Mutual Recognition Agreements: Five models of harmonization

Food and Drug Law Journal

Volumn 53, Issue 1, 1998, Pages 133-137

  Merrill, Richard A ^a,b  

^a UNIVERSITY OF VIRGINIA SCHOOL OF LAW   (United States)

^b Department of International Practice   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

CANADA; DEVICE; EUROPEAN UNION; FOOD; FOOD AND DRUG ADMINISTRATION; INTERNATIONAL COOPERATION; REVIEW; UNITED KINGDOM; UNITED STATES;

CANADA; COMMERCE; EUROPE; EUROPEAN UNION; HUMANS; INTERNATIONAL COOPERATION; MODELS, ORGANIZATIONAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031925010     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. Agreement on Mutual Recognition Between the United States of America and the European Community, June 20, 1997.
2. See generally PETER BARTON HUTT & RICHARD A. MERRILL, FOOD AND DRUG LAW CASES AND MATERIALS 922-928 (2d ed. 1991) (citing, in part, Saccharin and its Salts: Proposed Rulemaking, 42 Fed. Reg. 19,996 (Apr. 15, 1977)).
3. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
4. Ch. 288, 37 Stat. 309 (1912) (codified at 42 U.S.C. §§ 201-299 (1994)).
5. The foregoing tentative analysis has been overtaken by the very recent enactment of the FDA Modernization Act, which specifically contemplates that FDA may, and should, enter into agreements with regulatory officials of U.S. trading partners in order more efficiently and effectively to discharge its regulatory duties. See generally FDA Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2295.
6. Pub. L. No. 79-404, 60 Stat. 237 (1946) (codified in scattered sections of 5 U.S.C. (1994)).
7. Pub. L. No. 89-487, 80 Stat. 250 (1966) (codified at 5 U.S.C. § 552).
8. Pub. L. No. 92-463, 86 Stat. 776 (codified at 5 U.S.C. app.).