Matches in DBpedia 2015-10 for { <http://dbpedia.org/resource/Prescription_Drug_User_Fee_Act> ?p ?o }
- Prescription_Drug_User_Fee_Act abstract "The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.".
- Prescription_Drug_User_Fee_Act wikiPageExternalLink z?d102:HR06181:@@@R.
- Prescription_Drug_User_Fee_Act wikiPageExternalLink STATUTE-106-Pg4491.pdf.
- Prescription_Drug_User_Fee_Act wikiPageID "10531326".
- Prescription_Drug_User_Fee_Act wikiPageLength "22982".
- Prescription_Drug_User_Fee_Act wikiPageOutDegree "39".
- Prescription_Drug_User_Fee_Act wikiPageRevisionID "644853133".
- Prescription_Drug_User_Fee_Act wikiPageWikiLink ACT-UP.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink ACT_UP.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink AIDS_epidemic.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Biologic_license_application.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Biologics_License_Application.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Bristol-Myers_Squibb.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Burroughs_Wellcome.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Category:Food_and_Drug_Administration.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Category:Pharmaceuticals_policy.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Center_for_Biologics_Evaluation_and_Research.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Center_for_Drug_Evaluation_and_Research.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Democratic_Party_(United_States).
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Didanosine.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink AIDS.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Federal_Food,_Drug,_and_Cosmetic_Act.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Federal_Food,_Drug_and_Cosmetic_Act.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Food_and_Drug_Administration.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Food_and_Drug_Administration_Modernization_Act.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Food_and_Drug_Administration_Modernization_Act_of_1997.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink George_H.W._Bush.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink George_H._W._Bush.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink GlaxoSmithKline.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Government_Accountability_Office.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink John_Dingell.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Larry_Kramer.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Louis_Lasagna.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Medication.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Michigan.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink New_Drug_Application.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink New_drug_application_(FDA).
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Opportunistic_infection.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Orphan_Drug_Act.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Orphan_Drug_Act_of_1983.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Orphan_diseases.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink PhRMA.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Pharmaceutical_Research_and_Manufacturers_of_America.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Pharmaceutical_company.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Pharmaceutical_drug.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Pharmaceutical_industry.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Presidents_Emergency_Plan_for_AIDS_Relief.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Public_Health_and_Bioterrorism_Preparedness_Act.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Rare_disease.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Richard_Gelb.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Title_21_of_the_United_States_Code.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink United_States_Congress.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink United_States_House_Committee_on_Energy_and_Commerce.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink United_States_Senate_Committee_on_Health,_Education,_Labor,_and_Pensions.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink United_States_Senate_Committee_on_Health,_Education,_Labor_and_Pensions.
- Prescription_Drug_User_Fee_Act wikiPageWikiLink Zidovudine.
- Prescription_Drug_User_Fee_Act wikiPageWikiLinkText "Prescription Drug User Fee Act".
- Prescription_Drug_User_Fee_Act actsAmended Federal_Food,_Drug,_and_Cosmetic_Act.
- Prescription_Drug_User_Fee_Act actsAmended Federal_Food,_Drug_and_Cosmetic_Act.
- Prescription_Drug_User_Fee_Act citePublicLaw "102".
- Prescription_Drug_User_Fee_Act colloquialacronym "PDUFA, DSA".
- Prescription_Drug_User_Fee_Act committees United_States_House_Committee_on_Energy_and_Commerce.
- Prescription_Drug_User_Fee_Act effectiveDate "1992-10-29".
- Prescription_Drug_User_Fee_Act enactedBy "102".
- Prescription_Drug_User_Fee_Act hasPhotoCollection Prescription_Drug_User_Fee_Act.
- Prescription_Drug_User_Fee_Act introducedby "John Dingell".
- Prescription_Drug_User_Fee_Act introduceddate "1992-10-06".
- Prescription_Drug_User_Fee_Act introducedin "House".
- Prescription_Drug_User_Fee_Act leghisturl z?d102:HR06181:@@@R.
- Prescription_Drug_User_Fee_Act longtitle "An Act to amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes.".
- Prescription_Drug_User_Fee_Act nickname "Dietary Supplement Act of 1992".
- Prescription_Drug_User_Fee_Act passedbody "House".
- Prescription_Drug_User_Fee_Act passedbody "Senate".
- Prescription_Drug_User_Fee_Act passeddate "1992-10-06".
- Prescription_Drug_User_Fee_Act passeddate "1992-10-07".
- Prescription_Drug_User_Fee_Act passedvote "passed voice vote".
- Prescription_Drug_User_Fee_Act passedvote "passed without objection".
- Prescription_Drug_User_Fee_Act publicLawUrl STATUTE-106-Pg4491.pdf.
- Prescription_Drug_User_Fee_Act sectionsAmended "§ 379g et seq.".
- Prescription_Drug_User_Fee_Act shorttitle "Prescription Drug User Fee Act".
- Prescription_Drug_User_Fee_Act signeddate "1992-10-29".
- Prescription_Drug_User_Fee_Act signedpresident George_H.W._Bush.
- Prescription_Drug_User_Fee_Act signedpresident George_H._W._Bush.
- Prescription_Drug_User_Fee_Act titleAmended "21".
- Prescription_Drug_User_Fee_Act wikiPageUsesTemplate Template:Food_and_Drug_Administration.
- Prescription_Drug_User_Fee_Act wikiPageUsesTemplate Template:Infobox_U.S._legislation.
- Prescription_Drug_User_Fee_Act wikiPageUsesTemplate Template:Main.
- Prescription_Drug_User_Fee_Act wikiPageUsesTemplate Template:Reflist.
- Prescription_Drug_User_Fee_Act subject Category:Food_and_Drug_Administration.
- Prescription_Drug_User_Fee_Act subject Category:Pharmaceuticals_policy.
- Prescription_Drug_User_Fee_Act hypernym Law.
- Prescription_Drug_User_Fee_Act type Article.
- Prescription_Drug_User_Fee_Act type Drug.
- Prescription_Drug_User_Fee_Act type Person.
- Prescription_Drug_User_Fee_Act type Agency.
- Prescription_Drug_User_Fee_Act type Article.
- Prescription_Drug_User_Fee_Act type Drug.
- Prescription_Drug_User_Fee_Act comment "The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.".
- Prescription_Drug_User_Fee_Act label "Prescription Drug User Fee Act".
- Prescription_Drug_User_Fee_Act sameAs m.02qgyg2.