How personalized medicine is changing the rules of drug life exclusivity

Pharmacogenomics

Volumn 5, Issue 4, 2004, Pages 429-432

  Sullivan, Clark G ^a  

^a King and Spalding LLP   (United States)

Author keywords

Generic drugs; Hacth Waxman; Same labeling requirement

Indexed keywords

ABACAVIR; GENERIC DRUG; METAXALONE; MUSCLE RELAXANT AGENT; TRAMADOL;

ARTICLE; CLINICAL TRIAL; DIAGNOSTIC PROCEDURE; DIZZINESS; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG LABELING; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; FOOD DRUG INTERACTION; GENETICS; HEALTH CARE POLICY; HUMAN; PAIN; PATENT; PHARMACOGENOMICS; PROTEOMICS; TREATMENT PLANNING; UNITED STATES; VERTIGO;

DRUGS, GENERIC; HUMANS; INDIVIDUALITY; MOLECULAR DIAGNOSTIC TECHNIQUES; PHARMACOGENETICS; PHYSICIAN-PATIENT RELATIONS; UNITED STATES;

EID: 3142757246     PISSN: 14622416     EISSN: None     Source Type: Journal    
DOI: 10.1517/14622416.5.4.429     Document Type: Article

References (10)

1. USC § 355 (j)(2)(A)(iv).
2. HR Rep. No. 857 (Part I), 98th Cong., 2d Sess. 21-22, reprinted in USCCAN 2654-2655.
3. CFR § 314(a)(8)(iv).
4. CFR § 314.127(a)(7).
5. Bristol-Myers Squibb Co. vs Donna E Shalala 320 US App. DC 32, 91 F.3d 1493 (DC Cir. 1996).
6. Bristol-Myers Squibb Co. vs Donna E Shalala 320 US App. DC 32, 91 F.3d 1500 (DC Cir. 1996).
7. Bristol-Myers Squibb Co. vs Shalala. FDA's Approval Brief No. 95-5399 (DC Cir. Ct. of App.) at 21.
8. Bristol Myers Squibb Co. vs Shalala. FDA's Approval Brief No. 95-5399 (DC Cir. Ct. of App.) at 26.
9. CFR § 314.127(a)(7).
10. Lindpaintner K: The importance of being modest - reflections on the pharmacogenetics of abacavir. Pharmacogenomics 3(6), 835-838 (2002).