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.
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
NERFINISHED
ⓘ
Public Health Service Act NERFINISHED ⓘ |
| authorizes | Risk Evaluation and Mitigation Strategies NERFINISHED ⓘ |
| authorizesAppropriationsFor | Food and Drug Administration NERFINISHED ⓘ |
| concerns |
medical device user fees
ⓘ
prescription drug user fees ⓘ |
| creates | Pediatric Medical Device Safety and Improvement Act provisions NERFINISHED ⓘ |
| establishes | Food and Drug Administration Amendments Act Risk Evaluation and Mitigation Strategies authority NERFINISHED ⓘ |
| expandsAuthorityOf | Food and Drug Administration NERFINISHED ⓘ |
| hasAbbreviation | FDAAA NERFINISHED ⓘ |
| hasCongress | 110 ⓘ |
| hasCountry |
United States of America
ⓘ
surface form:
United States
|
| hasEnactmentDate | 2007-09-27 ⓘ |
| hasPublicLawNumber | P.L. 110-85 NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| hasStatutesAtLargeCitation | 121 Stat. 823 ⓘ |
| hasTitle | Food and Drug Administration Amendments Act of 2007 NERFINISHED ⓘ |
| hasType | public law ⓘ |
| includes | pediatric research and drug study provisions ⓘ |
| isPartOf | United States food and drug law NERFINISHED ⓘ |
| jurisdiction |
United States of America
ⓘ
surface form:
United States
|
| language | English ⓘ |
| reauthorizes |
Medical Device User Fee and Modernization Act
NERFINISHED
ⓘ
Prescription Drug User Fee Act NERFINISHED ⓘ |
| regulates |
Food and Drug Administration
NERFINISHED
ⓘ
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 NERFINISHED ⓘ |
| wasSignedBy | George W. Bush NERFINISHED ⓘ |
| yearOfEnactment | 2007 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.