FDAAA

E647146

United States federal law drug regulation law health law medical device regulation law

FDAAA is a U.S. federal law enacted in 2007 that expanded the Food and Drug Administration’s authority over drug and device safety, clinical trial registration, and post-market surveillance.

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Statements (48)

Predicate	Object
instanceOf	United States federal law ⓘ drug regulation law ⓘ health law ⓘ medical device regulation law ⓘ
abbreviationFor	Food and Drug Administration Amendments Act of 2007 NERFINISHED ⓘ
affects	clinical investigators ⓘ clinical trial sponsors ⓘ medical device manufacturers ⓘ pharmaceutical manufacturers ⓘ
aimsTo	improve drug safety monitoring ⓘ increase transparency of clinical research ⓘ strengthen post-market surveillance ⓘ
amends	Federal Food, Drug, and Cosmetic Act NERFINISHED ⓘ
authorizes	FDA to require Risk Evaluation and Mitigation Strategies ⓘ FDA to require post-marketing clinical trials ⓘ FDA to require post-marketing studies ⓘ
containsProvision	Section 801 – Expanded Clinical Trial Registry Data Bank NERFINISHED ⓘ Title VIII – Clinical Trial Databases NERFINISHED ⓘ
country	United States of America ⓘ surface form: United States
creates	Risk Evaluation and Mitigation Strategies program NERFINISHED ⓘ
effectiveIn	United States NERFINISHED ⓘ
enactedBy	United States Congress ⓘ
establishes	expanded post-marketing safety authorities for FDA ⓘ
expandsAuthorityOf	U.S. Food and Drug Administration NERFINISHED ⓘ
fullName	Food and Drug Administration Amendments Act of 2007 NERFINISHED ⓘ
hasKeyConcept	Risk Evaluation and Mitigation Strategies (REMS) NERFINISHED ⓘ clinical trial registry ⓘ clinical trial results database ⓘ post-market risk management ⓘ
jurisdiction	federal ⓘ
regulates	biological products ⓘ clinical trial registration ⓘ clinical trial results reporting ⓘ drug safety ⓘ medical device safety ⓘ post-market device surveillance ⓘ post-market drug surveillance ⓘ
requires	adverse event reporting for certain trials ⓘ registration of applicable clinical trials on ClinicalTrials.gov ⓘ results reporting for certain clinical trials on ClinicalTrials.gov ⓘ submission of basic summary results information ⓘ
signedBy	George W. Bush ⓘ
signingDate	2007-09-27 ⓘ
subjectArea	clinical research regulation ⓘ medical device regulation ⓘ pharmaceutical regulation ⓘ public health ⓘ
yearEnacted	2007 ⓘ

Referenced by (1)

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Food and Drug Administration Amendments Act of 2007 → abbreviation → FDAAA ⓘ