These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
4. Sandoz sues FDA over delay in first biogeneric approval. Fox JL Nat Biotechnol; 2005 Nov; 23(11):1327-8. PubMed ID: 16273046 [No Abstract] [Full Text] [Related]
7. Drug marketing exclusivity under United States and European Union law. Junod V Food Drug Law J; 2004; 59(4):479-518. PubMed ID: 15875347 [No Abstract] [Full Text] [Related]
8. Path to approval proves rocky for copycat biodrugs. Wadman M Nature; 2005 Nov; 438(7065):154-5. PubMed ID: 16281004 [No Abstract] [Full Text] [Related]
9. Takings issues in the approval of generic biologics. Yoo JC Food Drug Law J; 2005; 60(1):33-43. PubMed ID: 15940853 [No Abstract] [Full Text] [Related]
10. Recent developments help the defense of drug companies in 10b-5 cases. Salpeter AN; Hutchins H Food Drug Law J; 1996; 51(3):345-53. PubMed ID: 11797711 [No Abstract] [Full Text] [Related]
11. SuperGenerics: a better alternative for biogenerics. Charles SA Drug Discov Today; 2005 Apr; 10(8):533-5. PubMed ID: 15837591 [No Abstract] [Full Text] [Related]
12. The application of the patent laws to the drug approval process. Coggio BD; Cerrito FD Food Drug Law J; 1997; 52(4):345-55. PubMed ID: 10346669 [No Abstract] [Full Text] [Related]
15. Old drugs, new uses: solving a Hatch-Waxman patent predicament. McPhie DC Food Drug Law J; 2004; 59(1):155-68. PubMed ID: 15190929 [No Abstract] [Full Text] [Related]
16. The Drug Price Competition and Patent Term Restoration Act of 1984: fine-tuning the balance between the interests of pioneer and generic drug manufacturers. Soehnge H Food Drug Law J; 2003; 58(1):51-80. PubMed ID: 12739584 [No Abstract] [Full Text] [Related]
17. Betting on biogenerics. Dove A Nat Biotechnol; 2001 Feb; 19(2):117-20. PubMed ID: 11175723 [No Abstract] [Full Text] [Related]
19. Regulatory evaluation of biotechnology drugs: current trends in the United States. Sobel S Bioprocess Technol; 1991; 13():499-511. PubMed ID: 1367148 [No Abstract] [Full Text] [Related]
20. How FDA approves biotechnology drugs. Manuel SM; Piascik P Am Pharm; 1995 May; NS35(5):14-5. PubMed ID: 7611131 [No Abstract] [Full Text] [Related] [Next] [New Search]