Food and Drug Administration Modernization Act of 1997

E165705

United States federal statute health law

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.

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All labels observed (3)

Label	Occurrences
Food and Drug Administration Modernization Act of 1997 canonical	4
FDA Modernization Act	1
FDA Modernization Act of 1997	1

How this entity was disambiguated

This entity first appeared as the object of triple T1445200 — 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 Modernization Act of 1997
Context triple: [Federal Food, Drug, and Cosmetic Act, amendedBy, Food and Drug Administration Modernization Act of 1997]

A. 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.
B. Frank R. Lautenberg Chemical Safety for the 21st Century Act
The Frank R. Lautenberg Chemical Safety for the 21st Century Act is a 2016 U.S. law that modernized federal chemical regulation by strengthening safety reviews and oversight of chemicals used in commerce.
C. Comprehensive Methamphetamine Control Act of 1996
The Comprehensive Methamphetamine Control Act of 1996 is a U.S. federal law aimed at curbing the manufacture, distribution, and abuse of methamphetamine by tightening controls on precursor chemicals and enhancing law enforcement powers and penalties.
D. False Claims Amendments Act of 1986
The False Claims Amendments Act of 1986 is a major U.S. federal law that strengthened the government’s ability to combat fraud against federal programs by expanding whistleblower (qui tam) provisions and increasing penalties for false claims.
E. Anti-Drug Abuse Act of 1988
The Anti-Drug Abuse Act of 1988 is a U.S. federal law that expanded the war on drugs by increasing penalties, funding enforcement and treatment programs, and establishing a coordinated national drug control strategy.
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 Modernization Act of 1997
Target entity description: 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.

A. 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.
B. Frank R. Lautenberg Chemical Safety for the 21st Century Act
The Frank R. Lautenberg Chemical Safety for the 21st Century Act is a 2016 U.S. law that modernized federal chemical regulation by strengthening safety reviews and oversight of chemicals used in commerce.
C. Comprehensive Methamphetamine Control Act of 1996
The Comprehensive Methamphetamine Control Act of 1996 is a U.S. federal law aimed at curbing the manufacture, distribution, and abuse of methamphetamine by tightening controls on precursor chemicals and enhancing law enforcement powers and penalties.
D. False Claims Amendments Act of 1986
The False Claims Amendments Act of 1986 is a major U.S. federal law that strengthened the government’s ability to combat fraud against federal programs by expanding whistleblower (qui tam) provisions and increasing penalties for false claims.
E. Anti-Drug Abuse Act of 1988
The Anti-Drug Abuse Act of 1988 is a U.S. federal law that expanded the war on drugs by increasing penalties, funding enforcement and treatment programs, and establishing a coordinated national drug control strategy.
F. None of above. chosen

Statements (48)

Predicate	Object
instanceOf	United States federal statute ⓘ health law ⓘ
aimedAt	enhancing patient access to experimental therapies ⓘ modernization of FDA ⓘ speeding approval of drugs ⓘ speeding approval of medical devices ⓘ streamlining FDA regulatory procedures ⓘ
amends	Federal Food, Drug, and Cosmetic Act ⓘ
appliesTo	Food and Drug Administration ⓘ
authorizes	FDA to accept user fees for device review ⓘ FDA to rely on third-party review for some devices ⓘ dissemination of peer-reviewed journal articles on off-label uses under conditions ⓘ
country	United States ⓘ linked to: United States of America
enactedBy	United States Congress ⓘ
establishes	framework for risk-based regulation of devices ⓘ procedures for meetings and dispute resolution with FDA ⓘ requirements for clinical trial registration in certain contexts ⓘ
goal	improve patient access to new therapies ⓘ maintain standards for safety and effectiveness ⓘ reduce regulatory burden on industry ⓘ
includes	provisions on device tracking and postmarket surveillance ⓘ provisions on health claims for foods ⓘ provisions on pharmacy compounding ⓘ provisions on radiopharmaceuticals ⓘ
jurisdiction	federal regulation of food and drugs in the United States ⓘ
providesFor	expanded access to investigational devices ⓘ expanded access to investigational drugs ⓘ fast track designation for certain drugs ⓘ postmarketing studies requirements ⓘ use of surrogate endpoints in approval ⓘ
regulates	biological products approval ⓘ drug approval process ⓘ medical device approval process ⓘ
relatedTo	Food and Drug Administration Safety and Innovation Act ⓘ linked to: Food and Drug Administration Safety and Innovation Act of 2012 Prescription Drug User Fee Act ⓘ linked to: Prescription Drug User Fee Act of 1992
shortName	FDAMA ⓘ
signedBy	Bill Clinton ⓘ
signingPresident	Bill Clinton ⓘ
subject	biologics regulation ⓘ clinical trials ⓘ drug regulation ⓘ fast track drug approval ⓘ medical device regulation ⓘ off-label information dissemination ⓘ pediatric studies of drugs ⓘ pharmacy compounding ⓘ user fees ⓘ
timePeriod	1990s health policy reforms in the United States ⓘ

How these facts were elicited

Referenced by (6)

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 Modernization Act of 1997 ⓘ

FDC Act → amendedBy → Food and Drug Administration Modernization Act of 1997 ⓘ

Orphan Drug Act of 1983 → amendedBy → FDA Modernization Act of 1997 ⓘ

linked to: Food and Drug Administration Modernization Act of 1997

Prescription Drug User Fee Act of 1992 → relatedTo → Food and Drug Administration Modernization Act of 1997 ⓘ

FDAMA → fullName → Food and Drug Administration Modernization Act of 1997 ⓘ

FDAMA → shortName → FDA Modernization Act ⓘ