An overview of international cooperation

Food and Drug Law Journal

Volumn 52, Issue 2, 1997, Pages 197-201

  Holston, Sharon Smith ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

CONFERENCE PAPER; DRUG APPROVAL; DRUG DEVELOPMENT; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; GOVERNMENT; INTERNATIONAL COOPERATION; WORLD HEALTH ORGANIZATION;

DEVICE APPROVAL; DRUG APPROVAL; EUROPEAN UNION; HUMANS; INTERNATIONAL COOPERATION; JAPAN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030952682     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (11)

1. See generally Food and Drug Admin., Off. of Reg. Affairs.
2. DEPARTMENT OF HEALTH & HUMAN SERVS., FDA INTERNATIONAL COOPERATIVE AGREEMENTS MANUAL (1996).
3. See supra note 1.
4. Id.
5. Id.
6. See, e.g., FDA Week, in 2 INSIDE WASHINGTON, Nov. 15, 1996.
7. Pharmaceutical Research & Mfrs. of Am., ICH Coordinator (unpublished results of 1996 survey).
8. ICH Steering Comm., Discussion Paper of the European Federation of Pharmaceutical Industries' Associations (1996).
9. 61 Fed. Reg. 52,602 (Oct. 7, 1996).
10. 60 Fed. Reg. 65,096 (Dec. 18, 1995).
11. 60 Fed, Reg. 63,381 (Dec. 8, 1995).