Public Law 110-85

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Public Law 110-85 is a 2007 U.S. federal statute that significantly expanded the Food and Drug Administration’s authority over drug and medical device safety, post-market surveillance, and user fees.

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P.L. 110-85 1
Public Law 110-85 canonical 1

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Statements (46)

Predicate Object
instanceOf Act of Congress
United States federal statute
aimsTo enhance medical device safety oversight
improve drug safety monitoring
increase transparency of clinical trials
amends Federal Food, Drug, and Cosmetic Act
Public Health Service Act
authorizes Risk Evaluation and Mitigation Strategies
authorizesAppropriationsFor Food and Drug Administration
concerns medical device user fees
prescription drug user fees
creates Pediatric Medical Device Safety and Improvement Act provisions
establishes Food and Drug Administration Amendments Act Risk Evaluation and Mitigation Strategies authority
expandsAuthorityOf Food and Drug Administration
hasAbbreviation FDAAA
hasCongress 110
hasCountry United States
hasEnactmentDate 2007-09-27
hasPublicLawNumber P.L. 110-85
linked to: Public Law 110-85
hasSectionOn active surveillance systems for drug safety
labeling changes for safety reasons
pediatric device tracking and incentives
post-market risk management
hasShortTitle FDA Amendments Act of 2007
hasStatutesAtLargeCitation 121 Stat. 823
hasTitle Food and Drug Administration Amendments Act of 2007
hasType public law
includes pediatric research and drug study provisions
isPartOf United States food and drug law
jurisdiction United States
language English
reauthorizes Medical Device User Fee and Modernization Act
Prescription Drug User Fee Act
regulates Food and Drug Administration
medical devices
prescription drugs
requires clinical trial registration and results reporting on ClinicalTrials.gov
enhanced post-marketing drug safety studies
strengthens FDA post-market safety authorities
subject drug safety
medical device safety
post-market surveillance
user fees for drugs and medical devices
wasEnactedBy 110th United States Congress
wasSignedBy George W. Bush
yearOfEnactment 2007

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Public Law 110-85 hasPublicLawNumber P.L. 110-85
linked to: Public Law 110-85