128 related articles for article (PubMed ID: 8458175)
1. FDA issues regulations on accelerated drug-approval process.
Clin Pharm; 1993 Apr; 12(4):253-4. PubMed ID: 8458175
[No Abstract] [Full Text] [Related]
2. FDA evaluates accelerated approval process. Food and Drug Administration.
Common Factor; 1995 Apr; (no 10):18. PubMed ID: 11362343
[TBL] [Abstract][Full Text] [Related]
3. FDA reform in Congress: interview with Peter Barton Hutt. Food and Drug Administration. Interview by John S. James.
Hutt PB
AIDS Treat News; 1996 Apr; (no 245):4-5. PubMed ID: 11363623
[TBL] [Abstract][Full Text] [Related]
4. FDA reform in Congress: AIDS community absent. Food and Drug Administration.
James JS
AIDS Treat News; 1995 Apr; (no 220):4-5. PubMed ID: 11362320
[TBL] [Abstract][Full Text] [Related]
5. New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule.
Fed Regist; 1992 Dec; 57(239):58942-60. PubMed ID: 10123232
[TBL] [Abstract][Full Text] [Related]
6. Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring--FDA. Proposed rule.
Fed Regist; 1998 May; 63(99):28301-9. PubMed ID: 10179873
[TBL] [Abstract][Full Text] [Related]
7. FDA regulations. FDA shuts down sale of unregulated HIV drug.
AIDS Policy Law; 2004 Sep; 19(18):8. PubMed ID: 18680858
[No Abstract] [Full Text] [Related]
8. New drug and antibiotic regulations--FDA. Proposed rule.
Fed Regist; 1982 Oct; 47(202):46622-66. PubMed ID: 10262075
[TBL] [Abstract][Full Text] [Related]
9. FDA looks at full approval for d4T. Food and Drug Administration.
Posit Aware; 1996; 7(1):7. PubMed ID: 11363131
[TBL] [Abstract][Full Text] [Related]
10. Removal of regulations regarding certification of antibiotic drugs--FDA. Direct final rule.
Fed Regist; 1998 May; 63(91):26066-9. PubMed ID: 10179333
[TBL] [Abstract][Full Text] [Related]
11. FDA regulations for drug development.
Behrman RE; Woodcock J
Science; 2010 Jul; 329(5987):33; author reply 33. PubMed ID: 20595600
[No Abstract] [Full Text] [Related]
12. Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2009 Jul; 74(143):37163-8. PubMed ID: 19655468
[TBL] [Abstract][Full Text] [Related]
13. Surrogate endpoints and FDA's accelerated approval process.
Fleming TR
Health Aff (Millwood); 2005; 24(1):67-78. PubMed ID: 15647217
[TBL] [Abstract][Full Text] [Related]
14. Delegations of authority and organization; Center for Drug Evaluation and Research--FDA. Final rule.
Fed Regist; 1993 Apr; 58(61):17093-4. PubMed ID: 10125229
[TBL] [Abstract][Full Text] [Related]
15. The FDA and "privatization"--the drug approval process.
Rutherford EM
Food Drug Law J; 1995; 50 Spec():203-25. PubMed ID: 10343044
[No Abstract] [Full Text] [Related]
16. Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring; extension of comment period--FDA. Proposed rule; extension of comment period.
Fed Regist; 1998 Aug; 63(148):41219-20. PubMed ID: 10181522
[TBL] [Abstract][Full Text] [Related]
17. List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness--FDA. Proposed rule.
Fed Regist; 1998 Oct; 63(195):54082-9. PubMed ID: 10185826
[TBL] [Abstract][Full Text] [Related]
18. Bioavailability and bioequivalence requirements; abbreviated applications; proposed revisions--FDA. Proposed rule.
Fed Regist; 1998 Nov; 63(223):64222-8. PubMed ID: 10339051
[TBL] [Abstract][Full Text] [Related]
19. FDA reform in Congress: FDA's concerns. Food and Drug Administration.
James JS
AIDS Treat News; 1996 Apr; (no 245):5-7. PubMed ID: 11363624
[TBL] [Abstract][Full Text] [Related]
20. IL-2 for HIV: the long march toward FDA approval. Food and Drug Administration.
Sterritt C
GMHC Treat Issues; 1997 Sep; 11(9):1-3. PubMed ID: 11364749
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
