Regulatory Information
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Significant Amendments to the FD&C Act
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Significant Amendments to the FD&C Act:
Since 1980, listed chronologically; date shown is when the Public Law was approved. "Summary" indicates link to a summary of the law; other links are to full text. Provisions of these Public Laws are incorporated into the FD&C Act.
Infant Formula Act of 1980 (summary)
Public Law (PL) 96-359 (Oct. 26, 1980)Orphan Drug Act
PL 97-414 (Jan. 4, 1983)Drug Price Competition and Patent Term Restoration Act of 1984 (summary)
PL 98-417 (Sept. 24, 1984)Prescription Drug Marketing Act of 1987
PL 100-293 (Apr. 22, 1988)Generic Animal Drug and Patent Term Restoration Act of 1988 (summary)
PL 100-670 (Nov. 16, 1988)Nutrition Labeling and Education Act of 1990 (summary)
PL 101-535 (Nov. 8, 1990)Safe Medical Devices Act of 1990 (summary)
PL 101-629 (Nov. 28, 1990)Medical Device Amendments of 1992 (summary)
PL 102-300 (June 16, 1992)Prescription Drug Amendments of 1992; Prescription Drug User Fee Act of 1992
PL 102-571 (Oct. 29, 1992)Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994
PL 103-396 (Oct. 22, 1994)Dietary Supplement Health and Education Act of 1994
PL 103-417 (Oct. 25, 1994)FDA Export Reform and Enhancement Act of 1996
PL 104-134 (April 26, 1996)Food Quality Protection Act of 1996
PL 104-170 (Aug. 3, 1996)Animal Drug Availability Act of 1996
PL 104-250 (Oct. 9, 1996)Food and Drug Administration Modernization Act (FDAMA) of 1997
PL 105-115 (Nov. 21, 1997)Best Pharmaceuticals for Children Act
PL 107-109 (Jan. 4, 2002)Medical Device User Fee and Modernization Act (MDUFMA) of 2002
PL 107-250 (Oct. 26, 2002)Animal Drug User Fee Act of 2003
PL 108-130 (Nov. 18, 2003)Pediatric Research Equity Act of 2003
PL 108-155 (Dec. 3, 2003)Minor Use and Minor Species Animal Health Act of 2004
PL 108-282 (Aug. 2, 2004)Dietary Supplement and Nonprescription Drug Consumer Protection Act
PL 109-462 (Dec. 22, 2006)Food and Drug Administration Amendments Act (FDAAA) of 2007
PL 110-85 (Sept. 27, 2007)Family Smoking Prevention and Tobacco Control Act (Public Law 111-31)
PL 111-31 (June 22, 2009)- FDA Food Safety Modernization Act
PL 111-353 (Jan. 4, 2011)
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