Originator drug development

Food and Drug Law Journal

Volumn 54, Issue 2, 1999, Pages 227-232

  Findlay, Richard J ^a  

^a AT Kearney Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; NEW DRUG;

ADVERSE DRUG REACTION; CONFERENCE PAPER; DRUG APPROVAL; DRUG COST; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SCREENING; PATENT;

DRUG INDUSTRY; DRUGS, GENERIC; ECONOMIC COMPETITION; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; PATENTS; UNITED STATES;

EID: 0032798702     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (15)

1. Gerald J. Mossinghoff, Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process, 54 FOOD & DRUG L.J. 187, 193 (1999).
2. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat 1585 (codified at 15 U.S.C. §§ 68b-68c, 70b (1994); 21 U.S.C. §§ 301 note, 355, 360cc (1994); 28 U.S.C. § 2201 (1994); 35 U.S.C. §§ 156, 271, 282 (1994)).
3. The Center for the Study of Drug Development, located at Tufts University, is the source for the figures on drug development times and costs. The main chart was published by Parexel, a leading contract research organization, in MARK MATHIEU, NEW DRUG DEVELOPMENT: A REGULATORY OVERVIEW 19 (rev. ed. 1998). The book is a helpful source of information for those doing drug development and clinical work.
4. The source for this data is work done internally at A.T. Kearney, Inc., plus some data that is published by the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs.
5. Id.
6. The source of this information is trade information, the Office of Generic Drugs, and A.T. Kearney, Inc. interviews.
7. See 21 U.S.C. § 355.
8. Id. § 355(b)(2)(A)(iv) (FDCA § 505(b)(2)(A)(iv)).
9. Id. § 355(b)(2)(A)(iii) (FDCA § 505(b)(2)(A)(iii)).
10. Data compiled by A.T. Kearney, Inc.
11. Data compiled by A.T. Kearney, Inc.
12. A.T. KEARNEY, INC., PATENT EXPIRY AND THE BATTLE AGAINST GENERICS 7 (1998);
13. Richard J. Findlay, A Compelling Case for Brand Building, PHARM. EXEC., Feb. 1998, at 76.
14. See supra note 4.
15. Research and analysis by A. T. Kearney, Inc.