Pediatric Research Equity Act
GPTKB entity
Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:abbreviation |
gptkb:PREA
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:amendedBy |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
| gptkbp:appliesTo |
biologics license applications
new drug applications |
| gptkbp:category |
Pharmaceutical regulation in the United States
Pediatric law |
| gptkbp:codifiedIn |
21 U.S.C. § 355c
|
| gptkbp:dateEnacted |
2003
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| gptkbp:excludes |
orphan drugs
|
| https://www.w3.org/2000/01/rdf-schema#label |
Pediatric Research Equity Act
|
| gptkbp:purpose |
require pediatric studies for certain drugs and biological products
|
| gptkbp:relatedTo |
gptkb:Best_Pharmaceuticals_for_Children_Act
|
| gptkbp:requires |
pediatric assessment
|
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
| gptkbp:bfsLayer |
7
|