Food and Drug Administration Modernization Act of 1997
E165705
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.
All labels observed (2)
| Label | Occurrences |
|---|---|
| Food and Drug Administration Modernization Act of 1997 canonical | 3 |
| 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]
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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.
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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.
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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.
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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.
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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 of America
ⓘ
surface form:
United States
|
| 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 of 2012
ⓘ
surface form:
Food and Drug Administration Safety and Innovation Act
Prescription Drug User Fee Act of 1992 ⓘ
surface form:
Prescription Drug User Fee Act
|
| 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
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Food and Drug Administration Modernization Act of 1997 Description of subject: 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.
Referenced by (4)
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
ⓘ
this entity surface form:
FDA Modernization Act of 1997
Prescription Drug User Fee Act of 1992
→
relatedTo
→
Food and Drug Administration Modernization Act of 1997
ⓘ