Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:amendedBy |
Biologics Price Competition and Innovation Act
|
| gptkbp:appliesTo |
manufacturers of biological products
|
| gptkbp:citation |
gptkb:42_U.S.C._§_262
|
| gptkbp:codifiedIn |
gptkb:Title_42_of_the_United_States_Code
|
| gptkbp:enforcedBy |
gptkb:U.S._Department_of_Health_and_Human_Services
|
| gptkbp:governs |
interchangeable biological products
biosimilar products licensing of biological products |
| https://www.w3.org/2000/01/rdf-schema#label |
42 U.S.C. § 262
|
| gptkbp:originallyEnactedAs |
Section 351 of the Public Health Service Act
|
| gptkbp:partOf |
gptkb:United_States_Code
|
| gptkbp:requires |
biologics license application
|
| gptkbp:subject |
regulation of biological products
|
| gptkbp:bfsParent |
gptkb:Public_Law_78-410
gptkb:Section_351:_Regulation_of_Biological_Products |
| gptkbp:bfsLayer |
7
|