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 (2)

Label	Occurrences
Food and Drug Administration Modernization Act of 1997 canonical	3
FDA Modernization Act of 1997	1

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 ⓘ

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 ⓘ

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

Orphan Drug Act of 1983 → 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 ⓘ