First Clinical Research Laws, Regulations & Guidelines


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 U.S. Statute – Adverse Event Reporting  
 U.S. Statute Best Pharmaceuticals for Children Act 
 U.S. Statute – Control of Devices for Human Use 
 U.S. Statute Cooperative Research and Development Agreements  
 U.S. Statute – Criminal Penalties – Federal Heath Care Programs 
 U.S. Statute Debarment, Denial and Suspension 
 U.S. Statute Device Fees 
 U.S. Statute – Drug Fees 
 U.S. Statute – Expanded Access 
 U.S. Statute – False Claims Act 
 U.S. Statute Fast Track Products 
 U.S. Statute – FDA Modernization Act 
 U.S. Statute Federal Food, Drug, and Cosmetic Act 
 U.S. Statute Food and Drug Administration Amendments Act 
 U.S. Statute – Food and Drugs Act of 1906 (Repealed) 
 U.S. Statute Grants: Rare Diseases 
 U.S. Statute HIPAA 
 U.S. Statute – Improving Access to Clinical Trials Act of 2009 
 U.S. Statute Limitation on Physician Referrals 
 U.S. Statute Medical Device User Fee and Modernization Act 
 U.S. Statute Medical Products for Use in Emergencies 
 U.S. Statute – New Drugs 
 U.S. Statute Pediatric Research Equity Act 
 U.S. Statute Pediatric Studies of Drugs 
 U.S. Statute – Pediatric Uses 
 U.S. Statute Research on Transplantation of Fetal Tissue 
 U.S. Statute – The Orphan Drug Act (Amended) 
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