Food and Drug Administration Modernization Act of 1997

URI: https://gptkb.org/entity/Food_and_Drug_Administration_Modernization_Act_of_1997
GPTKB entity
Statements (25)
Predicate Object
gptkbp:instanceOf gptkb:United_States_federal_law
gptkbp:affects gptkb:Food_and_Drug_Administration
gptkbp:amendedBy gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:citation gptkb:111_Stat._2296
gptkbp:dateEnacted November 21, 1997
gptkbp:enactedBy gptkb:United_States_Congress
https://www.w3.org/2000/01/rdf-schema#label Food and Drug Administration Modernization Act of 1997
gptkbp:providesFor regulation of medical devices
clinical trial database
expanded access to investigational drugs
fast track drug approval
regulation of food contact substances
sunset of certain regulations
gptkbp:purpose to reform regulation of food, drugs, devices, and biological products
gptkbp:reformed drug approval process
food safety regulation
medical device approval process
gptkbp:relatedTo gptkb:Food_and_Drug_Administration
gptkbp:section Section 113 (clinical trial database)
Section 401 (sunset of regulations)
gptkbp:shortName gptkb:FDAMA
gptkbp:signedBy gptkb:Bill_Clinton
gptkbp:title gptkb:Public_Law_105-115
gptkbp:bfsParent gptkb:ClinicalTrials.gov
gptkbp:bfsLayer 5