Food and Drug Administration Safety and Innovation Act of 2012

E643466

United States federal statute health law

The Food and Drug Administration Safety and Innovation Act of 2012 is a U.S. federal law that reauthorized and expanded FDA user fee programs while enhancing the agency’s authority over drug and medical device safety, innovation, and supply chain oversight.

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All labels observed (3)

Label	Occurrences
Food and Drug Administration Safety and Innovation Act of 2012 canonical	2
Food and Drug Administration Safety and Innovation Act	1
Medical Device User Fee and Modernization Act reauthorization	1

How this entity was disambiguated

This entity first appeared as the object of triple T7110785 — 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 Safety and Innovation Act of 2012
Context triple: [FDC Act, amendedBy, Food and Drug Administration Safety and Innovation Act of 2012]

A. Food and Drug Administration Amendments Act of 2007
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.
B. 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.
C. 21st Century Cures Act
The 21st Century Cures Act is a U.S. federal law enacted in 2016 that accelerates medical product development and innovation, expands funding for biomedical research and mental health services, and modernizes the regulation of drugs and medical devices.
D. Biologics Price Competition and Innovation Act
The Biologics Price Competition and Innovation Act is a U.S. law that created an abbreviated regulatory pathway for approval of biosimilar and interchangeable biological products to promote competition while balancing incentives for innovation.
E. Prescription Drug User Fee Act of 1992
The Prescription Drug User Fee Act of 1992 is a U.S. law that authorizes the FDA to collect fees from pharmaceutical companies to fund and expedite the review of new drug applications.
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 Safety and Innovation Act of 2012
Target entity description: The Food and Drug Administration Safety and Innovation Act of 2012 is a U.S. federal law that reauthorized and expanded FDA user fee programs while enhancing the agency’s authority over drug and medical device safety, innovation, and supply chain oversight.

A. Food and Drug Administration Amendments Act of 2007
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.
B. 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.
C. 21st Century Cures Act
The 21st Century Cures Act is a U.S. federal law enacted in 2016 that accelerates medical product development and innovation, expands funding for biomedical research and mental health services, and modernizes the regulation of drugs and medical devices.
D. Biologics Price Competition and Innovation Act
The Biologics Price Competition and Innovation Act is a U.S. law that created an abbreviated regulatory pathway for approval of biosimilar and interchangeable biological products to promote competition while balancing incentives for innovation.
E. Prescription Drug User Fee Act of 1992
The Prescription Drug User Fee Act of 1992 is a U.S. law that authorizes the FDA to collect fees from pharmaceutical companies to fund and expedite the review of new drug applications.
F. None of above. chosen

Statements (47)

Predicate	Object
instanceOf	United States federal statute ⓘ health law ⓘ
affectsAgency	Center for Biologics Evaluation and Research NERFINISHED ⓘ Center for Devices and Radiological Health NERFINISHED ⓘ Center for Drug Evaluation and Research NERFINISHED ⓘ
appliesTo	Food and Drug Administration NERFINISHED ⓘ
authorizes	FDA to enhance postmarket surveillance ⓘ FDA to inspect foreign drug manufacturing facilities more frequently ⓘ FDA to require risk evaluation and mitigation strategies ⓘ
country	United States of America ⓘ surface form: United States
enactedBy	United States Congress ⓘ
establishes	user fees for biosimilar biological product applications ⓘ user fees for generic drug applications ⓘ
hasComponent	Biosimilar User Fee Act NERFINISHED ⓘ Generic Drug User Fee Amendments NERFINISHED ⓘ Medical Device User Fee Amendments reauthorization NERFINISHED ⓘ Prescription Drug User Fee Act reauthorization NERFINISHED ⓘ
includesProvision	breakthrough therapy designation framework ⓘ expedited drug development and review pathways ⓘ patient-focused drug development measures ⓘ pediatric drug and device provisions ⓘ
jurisdiction	federal ⓘ
policyArea	drug supply chain security ⓘ medical device regulation ⓘ pharmaceutical regulation ⓘ public health ⓘ
purpose	enhance drug safety oversight ⓘ enhance medical device safety oversight ⓘ expand FDA user fee authority ⓘ promote medical product innovation ⓘ reauthorize FDA user fee programs ⓘ strengthen drug supply chain security ⓘ
reauthorizes	Medical Device User Fee Amendments NERFINISHED ⓘ Prescription Drug User Fee Act NERFINISHED ⓘ
regulates	biologics ⓘ biosimilar biological products ⓘ drug supply chain ⓘ drugs ⓘ generic drugs ⓘ medical devices ⓘ
regulatoryBody	Food and Drug Administration NERFINISHED ⓘ
shortName	FDASIA NERFINISHED ⓘ
signedBy	Barack Obama NERFINISHED ⓘ
strengthens	FDA authority over drug shortages ⓘ FDA authority over imported drugs ⓘ FDA authority over medical device postmarket studies ⓘ
yearEnacted	2012 ⓘ

How these facts were elicited

Referenced by (4)

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

FDC Act → amendedBy → Food and Drug Administration Safety and Innovation Act of 2012 ⓘ

Orphan Drug Act of 1983 → amendedBy → Food and Drug Administration Safety and Innovation Act of 2012 ⓘ

Food and Drug Administration Modernization Act of 1997 → relatedTo → Food and Drug Administration Safety and Innovation Act of 2012 ⓘ

this entity surface form: Food and Drug Administration Safety and Innovation Act

Food and Drug Administration Amendments Act of 2007 → establishesProgram → Food and Drug Administration Safety and Innovation Act of 2012 ⓘ

this entity surface form: Medical Device User Fee and Modernization Act reauthorization

All labels observed (3)

How this entity was disambiguated Show

Statements (47)

How these facts were elicited Show

Referenced by (4)

How this entity was disambiguated

How these facts were elicited