Statements (31)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:amendedBy |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:category |
gptkb:Health_law
Pharmaceutical regulation Medical device regulation |
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:establishes |
ClinicalTrials.gov reporting requirements
|
| https://www.w3.org/2000/01/rdf-schema#label |
Public Law 110-85
|
| gptkbp:improves |
FDA regulatory powers
|
| gptkbp:officialName |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
| gptkbp:powers |
FDA postmarket drug safety authority
|
| gptkbp:providesFor |
reauthorization of the Best Pharmaceuticals for Children Act (BPCA)
reauthorization of the Pediatric Research Equity Act (PREA) reauthorization of the Prescription Drug User Fee Act (PDUFA) reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) |
| gptkbp:publicLawNumber |
110-85
|
| gptkbp:requires |
clinical trial registration and results reporting
|
| gptkbp:signedBy |
gptkb:George_W._Bush
September 27, 2007 |
| gptkbp:statutesAtLargeCitation |
gptkb:121_Stat._823
|
| gptkbp:subject |
gptkb:Food_and_Drug_Administration
clinical trials medical devices pediatric research drug safety medical product safety FDA authority prescription drug user fees |
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
gptkb:FDA_Amendments_Act_of_2007 |
| gptkbp:bfsLayer |
7
|