FDA’s antibiotic regulatory scheme: Then and now

The Pharmaceutical Regulatory Process, Second Edition

Volumn , Issue , 2008, Pages 131-141

  Wiesen, Irving L ^a  

^a Law Offices of Irving L Wiesen   (United States)

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EID: 84953746419     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (26)

1. FDCA §507(a), 21 USC 357(a).
2. Pub. L. No. 77-366, 55 Stat 851 (1941); Pub. L. No. 79-139, 59 Stat 463 (1945); codified at 21 USC 356.
3. FDCA §507(a), 21 USC 357.
4. John D. Harrision. Antibiotic Application Requirements. Clin Res Practices & Drug Reg Affairs 1986; 4(4);265, 267.
5. John D. Harrision. Antibiotic Application Requirements. Clin Res Practices & Drug Reg Affairs 1986; 4(4) at 267.
6. 21 USC 357(a).
7. See FDA Proposal, 47FR 19957. May 5, 1982; see also former 21 CFR 314.50, 314.55.
8. John D. Harrision. Antibiotic Application Requirements. Clin Res Practices & Drug Reg Affairs 1986; 4(4) at 269.
9. FDA Order, 47 FR 39155. September 7, 1982.
10. See Barr Laboratories, Inc. v. Harris, 482 F. Supp. 1183 (DDC 1980).
11. See Pfizer, Inc. v. Richardson, 434 F2 d 536 (2 d Cir 1970).
12. See In the Matter of Antibiotic Antifungal Drugs (FDA 1988). 1988-1989n FDC LRept Dev Trans Bind at 38070.
13. 21 CFR 433.1(a) (repealed).
14. See former 21 CFR 314.
15. See former 21 CFR 314.70.
16. 63 FR 26066.
17. 64 FR 396, 64 FR 26657 (May 17, 1999).
18. 21 CFR parts 430-460
19. Marketing Exclusivity and Patent Provisions for Certain Antibiotic Drugs. 65 FR 3623 (Jan. 24, 2000).
20. 65 FR 3623 (Jan. 24, 2000).
21. 65 FR (Jan. 24, 2000) at 3624.
22. 65 FR at 3625.
23. Guidance for Industry and Reviewers: Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act. FDA Center for Drug Evaluation and Research (“CDER”). May 1998.
24. Section 201(jj) of the FDCA.
25. Guidance for Industry: Drug Master Files for Bulk Antibiotic Drug Substances.FDA Center for Drug Evaluation and Research (“CDER”). November, 1999.
26. Civil Action No. 03-2236 (RMC). U.S. District Court. District of Columbia. (Jan. 19, 2005).