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

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 ⓘ

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