|
gptkbp:instance_of
|
gptkb:legislation
|
|
gptkbp:bfsLayer
|
4
|
|
gptkbp:bfsParent
|
gptkb:U._S._Food_and_Drug_Administration
|
|
gptkbp:amended_by
|
gptkb:Public_Health_Service_Act
|
|
gptkbp:applies_to
|
vaccines
blood products
cellular therapies
gene therapies
|
|
gptkbp:effective_date
|
1902
|
|
gptkbp:enacted_by
|
gptkb:legislation
|
|
gptkbp:enforces
|
gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
|
|
gptkbp:established
|
gptkb:Food_and_Drug_Administration
|
|
gptkbp:goal
|
ensure efficacy of biologics
ensure purity of biologics
ensure safety of biologics
|
|
gptkbp:historical_significance
|
first federal law regulating biological products
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Biologics Control Act
|
|
gptkbp:impact
|
gptkb:healthcare_organization
biotechnology industry
clinical research standards
regulatory framework for biologics
|
|
gptkbp:influenced_by
|
serum therapy controversies
|
|
gptkbp:regulates
|
gptkb:Company
|
|
gptkbp:related_to
|
gptkb:Public_Health_Service_Act
FDA regulations
Drug Approval Process
biologics license application
|
|
gptkbp:replaced_by
|
gptkb:Biologics_Control_Act_of_1972
|