U.S. Food and Drug Administration (FDA)

URI: https://gptkb.org/entity/U.S._Food_and_Drug_Administration_(FDA)

GPTKB entity

Statements (103)

Predicate	Object
gptkbp:instanceOf	gptkb:government_agency
gptkbp:abbreviation	gptkb:FDA
gptkbp:budget	over $6 billion
gptkbp:commissioner	gptkb:Robert_M._Califf
gptkbp:country	gptkb:United_States
gptkbp:employs	over 17,000 people
gptkbp:founded	1906
gptkbp:hasDivision	gptkb:Center_for_Biologics_Evaluation_and_Research_(CBER) gptkb:Center_for_Devices_and_Radiological_Health_(CDRH) gptkb:Center_for_Drug_Evaluation_and_Research_(CDER) gptkb:Center_for_Food_Safety_and_Applied_Nutrition_(CFSAN) gptkb:Center_for_Tobacco_Products_(CTP) gptkb:Center_for_Veterinary_Medicine_(CVM) gptkb:National_Center_for_Toxicological_Research_(NCTR) gptkb:Office_of_Regulatory_Affairs_(ORA) gptkb:Office_of_the_Commissioner
gptkbp:headquartersLocation	gptkb:Silver_Spring,_Maryland
https://www.w3.org/2000/01/rdf-schema#label	U.S. Food and Drug Administration (FDA)
gptkbp:jurisdiction	gptkb:federal_government_of_the_United_States
gptkbp:oversees	gptkb:510(k)_premarket_notification_for_medical_devices gptkb:ANDA_(Abbreviated_New_Drug_Application) gptkb:Accelerated_Approval_pathway gptkb:Animal_Drug_User_Fee_Act_(ADUFA) gptkb:Biologics_License_Applications_(BLA) gptkb:Biosimilar_User_Fee_Act_(BsUFA) gptkb:Breakthrough_Therapy_designation gptkb:Drug_Supply_Chain_Security_Act gptkb:Emergency_Use_Authorization_(EUA) gptkb:FDA_Adverse_Event_Reporting_System_(FAERS) gptkb:Fast_Track_designation gptkb:Food_Code gptkb:Food_Facility_Registration gptkb:Food_Safety_Modernization_Act_(FSMA) gptkb:GRAS_(Generally_Recognized_as_Safe)_substances gptkb:Generic_Drug_User_Fee_Amendments_(GDUFA) gptkb:Good_Manufacturing_Practice_(GMP)_regulations gptkb:Investigational_New_Drug_(IND)_applications gptkb:Medical_Device_User_Fee_Amendments_(MDUFA) gptkb:New_Drug_Applications_(NDA) gptkb:Nutrition_Facts_label gptkb:Orphan_Drug_Act gptkb:Orphan_Drug_designation gptkb:Premarket_Approval_(PMA)_for_medical_devices gptkb:Prescription_Drug_User_Fee_Act_(PDUFA) gptkb:Priority_Review_designation gptkb:Rare_Pediatric_Disease_Priority_Review_Voucher gptkb:Risk_Evaluation_and_Mitigation_Strategies_(REMS) gptkb:Vaccine_Adverse_Event_Reporting_System_(VAERS) Biologics Approval Process ClinicalTrials.gov registration Cosmetic Regulation Drug Approval Process Expanded Access (compassionate use) programs Food Additive Approval Process Food labeling regulations MedWatch safety information Medical Device Approval Process Pediatric exclusivity Tobacco Product Regulation Veterinary Product Regulation
gptkbp:parentOrganization	gptkb:U.S._Department_of_Health_and_Human_Services
gptkbp:regulates	gptkb:livestock clinical trials animal drugs biologics biosimilars blood products color additives compounded drugs food additives food contact substances food labeling generic drugs infant formula mammography facilities orphan drugs over-the-counter drugs prescription drugs medical device tobacco manufacturing drug recalls food recalls medical device recalls radiation-emitting electronic products biologic recalls cosmetic recalls dietary supplement recalls tobacco recalls vaccine recalls veterinary product recalls
gptkbp:responsibleFor	regulation of cosmetics regulation of dietary supplements regulation of medical devices regulation of tobacco products regulation of vaccines regulation of veterinary products regulation of food safety regulation of pharmaceuticals
gptkbp:website	https://www.fda.gov/
gptkbp:bfsParent	gptkb:Philip_Morris_USA gptkb:Rockville,_Maryland,_United_States gptkb:positron_emission_tomography_(PET)_imaging
gptkbp:bfsLayer	6