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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
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
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
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 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
THE NEW DRUG APPLICATION (NDA)   ,[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

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Anatomy of the foetal skull
Anatomy of the foetal skullAnatomy of the foetal skull
Anatomy of the foetal skull
 
Anatomy of the female pelvis
Anatomy of the female pelvisAnatomy of the female pelvis
Anatomy of the female pelvis
 
Active management of normal labour
Active management of normal labourActive management of normal labour
Active management of normal labour
 
Thyrotoxicosis in pregnancy
Thyrotoxicosis in pregnancyThyrotoxicosis in pregnancy
Thyrotoxicosis in pregnancy
 

Drug development and regulation

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