Drug development and regulation

DRUG DEVELOPMENT AND REGULATION www.freelivedoctor.com

Historical Background Why were Laws Needed? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Virus Toxin Act of 1902 ,[object Object],[object Object],[object Object],www.freelivedoctor.com

Food and Drug Act of l906 (Wiley or Heyburn Act) ,[object Object],[object Object],[object Object],www.freelivedoctor.com

The Sherley Amendment of l912 ,[object Object],[object Object],www.freelivedoctor.com

The Food, Drug and Cosmetic Act of l938 (Copeland Act) ,[object Object],[object Object],[object Object],www.freelivedoctor.com

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Act – l947 ,[object Object],[object Object],[object Object],www.freelivedoctor.com

The Durham Humphrey Amendment of l951 ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Insulin and Antibiotic Certification Amendments ’41, ’43, ’45, ’49, ’52 ,[object Object],[object Object],www.freelivedoctor.com

The Kefauver – Harris Act of l962 ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

DESI Evaluation of l966; completed l969-70 ,[object Object],www.freelivedoctor.com

Comprehensive Drug Abuse Prevention and Control Act of 1970 ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Important Legislative Developments of the 70’s ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Orphan Drug Act of 1983 ,[object Object],[object Object],www.freelivedoctor.com

Drug Price Competition and Patent Term Restoration Act – 1984 ,[object Object],[object Object],[object Object],www.freelivedoctor.com

Generic Drugs Act – 1990 ,[object Object],[object Object],www.freelivedoctor.com

Prescription Drug User Fee Act (PDUFA) of l994; l997; 2000; 2003 ,[object Object],[object Object],www.freelivedoctor.com

FDA Modernization Act - l997 ,[object Object],[object Object],www.freelivedoctor.com

Pediatric Exclusivity Act of 1998 ,[object Object],[object Object],www.freelivedoctor.com

Drug Development - Methods used to identify compounds with potential therapeutic usefulness ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Synthesis, Purification & Data Mining ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Animal Studies - Preclinical Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Animal Studies - Preclinical Studies ,[object Object],[object Object],[object Object],www.freelivedoctor.com

Clinical Studies ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Clinical Studies (continued) ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Clinical Studies (continued) ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

DEFINITION OF A NEW DRUG ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

INVESTIGATIONAL NEW DRUG APPLICATION (IND) ,[object Object],www.freelivedoctor.com

INVESTIGATIONAL NEW DRUG APPLICATION (IND) ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

PHASE I STUDIES ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

PHASE I STUDIES ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

PHASE II STUDIES ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

PHASE III STUDIES ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

PHASE III STUDIES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

THE NEW DRUG APPLICATION (NDA) ,[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

PHASE IV – POSTMARKETING SURVEILLANCE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

PHASE IV – POSTMARKETING SURVEILLANCE ,[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

CLASSIFICATION SYSTEM Type - Review Priorities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

CLASSIFICATION SYSTEM Type - Review Priorities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],www.freelivedoctor.com

Drug development and regulation

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