Section 351: Regulation of Biological Products
GPTKB entity
Statements (20)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:amendedBy |
gptkb:Biologics_Price_Competition_and_Innovation_Act_of_2009
|
| gptkbp:appliesTo |
blood products
cellular therapies gene therapies vaccines |
| gptkbp:approvedBy |
FDA to approve biological products
FDA to inspect manufacturing facilities |
| gptkbp:codifiedIn |
gptkb:42_U.S.C._§_262
|
| gptkbp:dateEnacted |
1944
|
| gptkbp:enforcedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:establishes |
requirements for safety, purity, and potency
|
| https://www.w3.org/2000/01/rdf-schema#label |
Section 351: Regulation of Biological Products
|
| gptkbp:partOf |
gptkb:Public_Health_Service_Act
|
| gptkbp:prohibits |
unlicensed biological product distribution
|
| gptkbp:providesFor |
biosimilar product approval pathway
|
| gptkbp:regulates |
biological products
|
| gptkbp:requires |
licensure of biological products
|
| gptkbp:bfsParent |
gptkb:Public_Health_Service_Act
|
| gptkbp:bfsLayer |
6
|