|
gptkbp:instance_of
|
gptkb:legislation
|
|
gptkbp:addresses
|
supply chain issues
drug shortages
|
|
gptkbp:amended_by
|
subsequent legislation
subsequent reauthorization acts
|
|
gptkbp:amends
|
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
|
gptkbp:contains
|
provisions for biosimilars
provisions for pediatric studies
provisions for generic drugs
|
|
gptkbp:effective_date
|
varies by version
|
|
gptkbp:enacted_by
|
gptkb:United_States_Congress
|
|
gptkbp:enhances
|
FDA's regulatory authority
|
|
gptkbp:facilitates
|
faster drug approvals
|
|
gptkbp:has_version
|
2022 version
2012 version
2017 version
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
Food and Drug Administration Reauthorization Act
|
|
gptkbp:impact
|
gptkb:pharmaceuticals
public health
FDA funding
|
|
gptkbp:includes
|
user fee agreements
|
|
gptkbp:influences
|
healthcare policies
|
|
gptkbp:introduced_in
|
gptkb:House_of_Representatives
gptkb:Senate
|
|
gptkbp:is_cited_in
|
gptkb:academic_research
gptkb:legal_case
news articles
government reports
policy papers
|
|
gptkbp:is_criticized_for
|
consumer advocacy groups
some healthcare professionals
|
|
gptkbp:is_debated_in
|
gptkb:United_States_Congress
|
|
gptkbp:is_discussed_in
|
public forums
legislative hearings
|
|
gptkbp:is_evaluated_by
|
gptkb:FDA
gptkb:NIH
|
|
gptkbp:is_implemented_in
|
gptkb:FDA
|
|
gptkbp:is_part_of
|
public health law
|
|
gptkbp:is_related_to
|
gptkb:Orphan_Drug_Act
gptkb:Affordable_Care_Act
gptkb:Food_and_Drug_Administration_Safety_and_Innovation_Act
gptkb:Drug_Price_Competition_and_Patent_Term_Restoration_Act
Prescription Drug User Fee Act
|
|
gptkbp:is_reviewed_by
|
gptkb:GAO
gptkb:CBO
|
|
gptkbp:is_supported_by
|
pharmaceutical companies
patient advocacy groups
|
|
gptkbp:promotes
|
innovation in drug development
|
|
gptkbp:purpose
|
to reauthorize user fees for FDA
|
|
gptkbp:related_to
|
drug approval process
biologics regulation
medical device regulation
|
|
gptkbp:requires
|
annual reports from FDA
|
|
gptkbp:signed_by
|
gptkb:President_of_the_United_States
|
|
gptkbp:supports
|
research and development
|
|
gptkbp:bfsParent
|
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
|
gptkbp:bfsLayer
|
5
|