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First Clinical Research Laws, Regulations & Guidelines


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 U.S. Statute – Adverse Event Reporting  
 U.S. Statute – Criminal Penalties – Federal Heath Care Programs 
 U.S. Statute – Drug Fees 
 U.S. Statute – Expanded Access 
 U.S. Statute – False Claims Act 
 U.S. Statute – FDA Modernization Act 
 U.S. Statute – Food and Drugs Act of 1906 (Repealed) 
 U.S. Statute – New Drugs 
 U.S. Statute - Pediatric Studies of Drugs 
 U.S. Statute - The Orphan Drug Act (Amended) 
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