US Food and Drug Administration – Important Milestones

YearLaw
1820U.S. Pharmacopeia
1848Drug Importation Act
1862Bureau of Chemistry
1883Dr. Harvey W. Wiley – “Father of the Pure Food and Drugs Act.”
1898Committee on Food Standards
1902The Biologics Control Act 
1906The Food and Drugs Act  The Meat Inspection Act
1907First Certified Color Regulations
1912Sherley Amendment
1913Gould Amendment 
1914The Harrison Narcotic Act 
1927Bureau of Chemistry = Food, Drug, and Insecticide Administration + Bureau of Chemistry and Soils
1930McNary­Mapes Amendment                   Short form – Food and Drug Administration (FDA)
1933revision of the obsolete 1906 Food and Drugs Act
1935publication of the Federal Register
1937Elixir of Sulfanilamide – Tragedy
1938The Federal Food, Drug, and Cosmetic (FDC) Act of 1938
1939First Food Standards 
1940FDA transferred from the Department of Agriculture to the Federal Security Agency
1941Insulin Amendment 
1943Public Health Service Act 
1944Penicillin Amendment 
1945Miller Amendment 
1948Oleomargarine Act 
1951Durham­Humphrey Amendment 
1952FDA consumer consultants are appointed 
1953Federal Security Agency becomes the Department of Health, Education, and Welfare (HEW)                                                                                      Factory Inspection Amendment 
1955The Division of Biologics Control 
1958Food Additives Amendment   first GRAS
1960Color Additive Amendment  Federal Hazardous Substances Labeling Act
1962Thalidomide Kefauver­Harris Drug Amendments 
1965Drug Abuse Control Amendments 
1966Child Protection Act   Fair Packaging and Labeling Act
1968FDA Bureau of Drug Abuse Control/Drug Efficacy Study Implementation (DESI)/Animal Drug Amendments 
1970Comprehensive Drug Abuse Prevention and Control Act /Environmental Protection Agency 
1971PHS Bureau of Radiological Health/National Center for Toxicological Research
1972Over­the­Counter Drug Review/Regulation of Biologics
1973Consumer Product Safety Commission
1976Medical Device Amendments/Vitamins and Minerals Amendments 
1980Infant Formula Act 
1981regulations for human subject protections
1982Tamper­resistant Packing Regulations 
1983Orphan Drug Act 
1984Drug Price Competition and Patent Term Restoration Act 
1986Childhood Vaccine Act 
1987Investigational drug regulations revised 
1988Food and Drug Administration Act/Generic Animal Drug and Patent Term Restoration Act 
1990Anabolic Steroid Act of 1990/Nutrition Labeling and Education Act / Safe Medical Devices Act
1991Accelerate the Review of Drugs for life­threatening diseases
1992Generic Drug Enforcement Act /Prescription Drug User Fee Act 
1994Animal Drug Availability Act /Food Quality Protection Act
1997Food and Drug Administration Modernization Act
1998Pediatric Rule
1999ClinicalTrials.gov is founded 
2000Data Quality Act
2002The Best Pharmaceuticals for Children Act
2003Medicare Prescription Drug Improvement and Modernization Act 
2004Project BioShield Act of 2004 
2005Drug Safety Board 
2009Family Smoking Prevention and Tobacco Control Act/ Center for Tobacco Products established
2011FDA Food Safety and Modernization Act (FSMA).
2012Food and Drug Administration Safety and Innovation Act (FDASIA)/ Medical Device User Fee and Modernization Act (MDUFMA III)
2013Drug Quality and Security Act/Pandemic and All­ Hazards Preparedness Reauthorization Act (PAHPRA)

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Important and Useful FDA links

Home http://www.fda.gov/ CFR http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm Orange book http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm BMIS http://www.accessdata.fda.gov/scripts/cder/bmis/index.cfm Clinical Investigator Search http://www.accessdata.fda.gov/scripts/cder/cliil/index.cfm Dissolution Database http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm Drug Establishment Registration http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm Drug Shortages http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm…

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