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3. The Food and Drug Administration's requirements for approval of new dental drugs. Gilkes CC Symp Pharmacol Ther Toxicol Group; 1975 Apr; ():5-12. PubMed ID: 1064180 [No Abstract] [Full Text] [Related]
5. Drug metabolites in safety testing. Baillie TA; Cayen MN; Fouda H; Gerson RJ; Green JD; Grossman SJ; Klunk LJ; LeBlanc B; Perkins DG; Shipley LA Toxicol Appl Pharmacol; 2002 Aug; 182(3):188-96. PubMed ID: 12229863 [TBL] [Abstract][Full Text] [Related]
6. The drug regulatory system of the United States Food and Drug Administration: a defense of current requirements for safety and efficacy. Simmons HE Int J Health Serv; 1974; 4(1):95-107. PubMed ID: 4829901 [No Abstract] [Full Text] [Related]
7. Kelsey's Commandos: FDA investigates the investigators. Small WE Am Pharm; 1979 Jun; 19(6):30-3. PubMed ID: 463736 [No Abstract] [Full Text] [Related]
8. Enforcement policy: recalls (including product corrections)--guidelines on policy, procedures, and industry responsibilities. Fed Regist; 1978 Jun; 43(117):26201-21. PubMed ID: 10316619 [No Abstract] [Full Text] [Related]
9. The development and regulation of new medications. Lasagna L Science; 1978 May; 200(4344):871-3. PubMed ID: 644328 [TBL] [Abstract][Full Text] [Related]
10. Medicolegal aspects of drug testing and systems of institutional review. Am J Cardiol; 1974 Oct; 34(4):482-4. PubMed ID: 4606800 [No Abstract] [Full Text] [Related]
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12. The role of clinical guidelines in research: FDA's viewpoint. Freeman MM J Clin Pharmacol; 1977; 17(11-12):682-5. PubMed ID: 925187 [No Abstract] [Full Text] [Related]
13. Ethical implications of withdrawal of experimental drugs at the conclusion of phase III trials. Roginsky MS; Handley A Clin Res; 1978 Dec; 26(6):384-8. PubMed ID: 10239695 [No Abstract] [Full Text] [Related]
15. Progress under the Kefauver-Harris Drug Amendments. Rankin WB Pharmakotherapia; 1964; 2(1):215-22. PubMed ID: 5875717 [No Abstract] [Full Text] [Related]
16. Prospects for reform of the IND/NDA processes: Part I. Romansky MA J Clin Psychopharmacol; 1982 Oct; 2(5):358-61. PubMed ID: 6752215 [No Abstract] [Full Text] [Related]
17. [How to improve drug development and utilization in pediatrics]. Pons G; Lassale C; Eschwege E Therapie; 1999; 54(4):423-32. PubMed ID: 10667109 [TBL] [Abstract][Full Text] [Related]
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19. Patients' needs in drug development and regulation. Wardell WM Ann N Y Acad Sci; 1981; 368():187-202. PubMed ID: 7020538 [No Abstract] [Full Text] [Related]
20. The effect of the Drug Regulation Reform Act of 1978 on clinical research, drug availability, and the public health. Temple RJ Ann N Y Acad Sci; 1981; 368():175-85. PubMed ID: 7020537 [No Abstract] [Full Text] [Related] [Next] [New Search]