Food and Drug Administration Amendments Act of 2007

URI: https://gptkb.org/entity/Food_and_Drug_Administration_Amendments_Act_of_2007
GPTKB entity
Statements (23)
Predicate Object
gptkbp:instanceOf gptkb:United_States_federal_law
gptkbp:amendedBy gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:approvedBy gptkb:Best_Pharmaceuticals_for_Children_Act
gptkb:Medical_Device_User_Fee_and_Modernization_Act
gptkb:Pediatric_Research_Equity_Act
gptkb:Prescription_Drug_User_Fee_Act
FDA to require Risk Evaluation and Mitigation Strategies (REMS)
gptkbp:citation gptkb:121_Stat._823
gptkbp:country gptkb:United_States
gptkbp:dateEnacted September 27, 2007
gptkbp:enactedBy gptkb:United_States_Congress
gptkbp:establishes ClinicalTrials.gov registration requirements
https://www.w3.org/2000/01/rdf-schema#label Food and Drug Administration Amendments Act of 2007
gptkbp:publicLawNumber gptkb:Public_Law_110-85
gptkbp:purpose to improve drug safety
to improve medical device safety
to increase transparency in clinical trials
gptkbp:regulates gptkb:Food_and_Drug_Administration
gptkbp:requires postmarket studies for drugs
gptkbp:shortName gptkb:FDAAA
gptkbp:signedBy gptkb:George_W._Bush
gptkbp:bfsParent gptkb:FDAAA_801
gptkbp:bfsLayer 6