Food and Drug Administration Amendments Act of 2007

E167140

United States federal statute health law

The Food and Drug Administration Amendments Act of 2007 is a U.S. law that expanded the FDA’s authority over drug and device safety, clinical trials, and post-market surveillance, while enhancing transparency and user fee programs.

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All labels observed (4)

Label	Occurrences
Food and Drug Administration Amendments Act of 2007 canonical	2
FDA Amendments Act of 2007	1
Title II—Medical Device User Fee Amendments of 2007	1
Title I—Prescription Drug User Fee Amendments of 2007	1

Statements (48)

Predicate	Object
instanceOf	United States federal statute ⓘ health law ⓘ
abbreviation	FDAAA ⓘ
aimsTo	enhance FDA resources through user fees ⓘ improve device safety monitoring ⓘ improve drug safety monitoring ⓘ increase transparency of clinical research ⓘ strengthen post-market surveillance ⓘ
amends	Federal Food, Drug, and Cosmetic Act ⓘ
containsProvision	active risk communication to healthcare professionals ⓘ drug labeling safety updates ⓘ pediatric research incentives ⓘ post-market risk identification and analysis system ⓘ
country	United States of America ⓘ surface form: United States
creates	FDA Risk Evaluation and Mitigation Strategies authority ⓘ FDA authority to mandate clinical trial registration ⓘ FDA authority to mandate clinical trial results reporting ⓘ FDA authority to require post-marketing clinical trials ⓘ FDA authority to require post-marketing studies ⓘ FDA authority to require safety-related labeling changes ⓘ FDA authority to restrict distribution of certain drugs ⓘ
effectiveIn	United States of America ⓘ surface form: United States
enactedBy	110th United States Congress ⓘ
establishes	ClinicalTrials.gov results reporting requirements ⓘ
establishesProgram	Food and Drug Administration Safety and Innovation Act of 2012 ⓘ surface form: Medical Device User Fee and Modernization Act reauthorization Prescription Drug User Fee Act of 1992 ⓘ surface form: Prescription Drug User Fee Act reauthorization pediatric drug user fee program ⓘ
expandsAuthorityOf	Food and Drug Administration ⓘ surface form: U.S. Food and Drug Administration
hasSection	Food and Drug Administration Amendments Act of 2007 self-linksurface differs ⓘ surface form: Title II—Medical Device User Fee Amendments of 2007 Food and Drug Administration Amendments Act of 2007 self-linksurface differs ⓘ surface form: Title I—Prescription Drug User Fee Amendments of 2007 Title VIII—Clinical Trial Databases ⓘ
legalDomain	food and drug law ⓘ public health law ⓘ
primaryAgencyAffected	Food and Drug Administration ⓘ surface form: U.S. Food and Drug Administration
publicLawNumber	Public Law 110-85 ⓘ
regulates	biological products ⓘ clinical trials of drugs and devices ⓘ medical devices ⓘ prescription drugs ⓘ
shortName	Food and Drug Administration Amendments Act of 2007 self-linksurface differs ⓘ surface form: FDA Amendments Act of 2007
signedBy	George W. Bush ⓘ
signingDate	2007-09-27 ⓘ
subjectOf	clinical trial transparency ⓘ device safety ⓘ drug safety ⓘ post-market surveillance ⓘ
title	An Act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish a user-fee program for pediatric drugs, and for other purposes ⓘ
yearEnacted	2007 ⓘ

Referenced by (5)

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

Federal Food, Drug, and Cosmetic Act → amendedBy → Food and Drug Administration Amendments Act of 2007 ⓘ

FDC Act → amendedBy → Food and Drug Administration Amendments Act of 2007 ⓘ

Food and Drug Administration Amendments Act of 2007 → shortName → Food and Drug Administration Amendments Act of 2007 self-linksurface differs ⓘ

this entity surface form: FDA Amendments Act of 2007

Food and Drug Administration Amendments Act of 2007 → hasSection → Food and Drug Administration Amendments Act of 2007 self-linksurface differs ⓘ

this entity surface form: Title I—Prescription Drug User Fee Amendments of 2007

Food and Drug Administration Amendments Act of 2007 → hasSection → Food and Drug Administration Amendments Act of 2007 self-linksurface differs ⓘ

this entity surface form: Title II—Medical Device User Fee Amendments of 2007