Public Law 110-85

E651087

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.

All labels observed (2)

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

How this entity was disambiguated

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 ⓘ

How these facts were elicited

Referenced by (2)

Full triples — surface form annotated when it differs from this entity's canonical label.

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