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 (5)

Label	Occurrences
Food and Drug Administration Amendments Act of 2007 canonical	7
FDA Amendments Act of 2007	2
Title II—Medical Device User Fee Amendments of 2007	1
Title I—Prescription Drug User Fee Amendments of 2007	1
U.S. Food and Drug Administration Amendments Act of 2007	1

How this entity was disambiguated

This entity first appeared as the object of triple T1445201 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.

NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07

Target entity: Food and Drug Administration Amendments Act of 2007
Context triple: [Federal Food, Drug, and Cosmetic Act, amendedBy, Food and Drug Administration Amendments Act of 2007]

A. Food and Drug Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act of 1997 is a U.S. law that overhauled FDA regulatory procedures to speed the approval of drugs and medical devices while enhancing patient access to experimental therapies and modernizing agency operations.
B. Drug Price Competition and Patent Term Restoration Act of 1984
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a U.S. law that streamlined the approval of generic drugs while providing patent term extensions to brand-name drug manufacturers to balance innovation and competition.
C. Kefauver–Harris Drug Amendments of 1962
The Kefauver–Harris Drug Amendments of 1962 are U.S. federal regulations that strengthened drug safety and efficacy requirements, mandating proof of effectiveness and stricter oversight of pharmaceutical marketing and manufacturing.
D. Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.
E. Ryan Haight Online Pharmacy Consumer Protection Act of 2008
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 is a U.S. federal law that regulates internet pharmacies by requiring valid prescriptions and in-person medical evaluations before dispensing controlled substances online.
F. None of above. chosen
G. Unsure - the case is ambiguous/there is not enough information to decide.

NED2 Entity disambiguation (via description) gpt-5-mini-2025-08-07

Target entity: Food and Drug Administration Amendments Act of 2007
Target entity description: 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.

A. Food and Drug Administration Modernization Act of 1997
The Food and Drug Administration Modernization Act of 1997 is a U.S. law that overhauled FDA regulatory procedures to speed the approval of drugs and medical devices while enhancing patient access to experimental therapies and modernizing agency operations.
B. Drug Price Competition and Patent Term Restoration Act of 1984
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a U.S. law that streamlined the approval of generic drugs while providing patent term extensions to brand-name drug manufacturers to balance innovation and competition.
C. Kefauver–Harris Drug Amendments of 1962
The Kefauver–Harris Drug Amendments of 1962 are U.S. federal regulations that strengthened drug safety and efficacy requirements, mandating proof of effectiveness and stricter oversight of pharmaceutical marketing and manufacturing.
D. Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.
E. Ryan Haight Online Pharmacy Consumer Protection Act of 2008
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 is a U.S. federal law that regulates internet pharmacies by requiring valid prescriptions and in-person medical evaluations before dispensing controlled substances online.
F. None of above. chosen

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 ⓘ linked to: United States of America
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 ⓘ linked to: United States of America
enactedBy	110th United States Congress ⓘ
establishes	ClinicalTrials.gov results reporting requirements ⓘ
establishesProgram	Medical Device User Fee and Modernization Act reauthorization ⓘ linked to: Food and Drug Administration Safety and Innovation Act of 2012 Prescription Drug User Fee Act reauthorization ⓘ linked to: Prescription Drug User Fee Act of 1992 pediatric drug user fee program ⓘ
expandsAuthorityOf	U.S. Food and Drug Administration ⓘ linked to: Food and Drug Administration
hasSection	Title II—Medical Device User Fee Amendments of 2007 ⓘ linked to: Food and Drug Administration Amendments Act of 2007 Title I—Prescription Drug User Fee Amendments of 2007 ⓘ linked to: Food and Drug Administration Amendments Act of 2007 Title VIII—Clinical Trial Databases ⓘ
legalDomain	food and drug law ⓘ public health law ⓘ
primaryAgencyAffected	U.S. Food and Drug Administration ⓘ linked to: Food and Drug Administration
publicLawNumber	Public Law 110-85 ⓘ
regulates	biological products ⓘ clinical trials of drugs and devices ⓘ medical devices ⓘ prescription drugs ⓘ
shortName	FDA Amendments Act of 2007 ⓘ linked to: Food and Drug Administration 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 ⓘ

How these facts were elicited

Referenced by (12)

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 → FDA Amendments Act of 2007 ⓘ