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- FDA_Special_Protocol_Assessment abstract "A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.Three types of protocols related to PDUFA products are eligible for this special protocol assessment under the PDUFA goals: animal carcinogenicity protocols, final product stability protocols, clinical protocols for phase 3 trials whose data will form the primary basis for an efficacy claim if the trials had been the subject of discussion at an end-of-phase 2/pre-phase 3 meeting with the review division, or in some cases, if the division agrees to such a review because the division is aware of the developmental context in which the protocol is being reviewed and the questions are being answered.The clinical protocols for phase 3 trials can relate to efficacy claims that will be part of an original new drug application (NDA) or Biologic License Application (BLA) or that will be part of an efficacy supplement to an approved NDA or BLA.".
- FDA_Special_Protocol_Assessment wikiPageExternalLink protocol.pdf.
- FDA_Special_Protocol_Assessment wikiPageID "12327567".
- FDA_Special_Protocol_Assessment wikiPageLength "1700".
- FDA_Special_Protocol_Assessment wikiPageOutDegree "10".
- FDA_Special_Protocol_Assessment wikiPageRevisionID "687806564".
- FDA_Special_Protocol_Assessment wikiPageWikiLink Biologic_license_application.
- FDA_Special_Protocol_Assessment wikiPageWikiLink Category:Food_and_Drug_Administration.
- FDA_Special_Protocol_Assessment wikiPageWikiLink Category:Life_sciences_industry.
- FDA_Special_Protocol_Assessment wikiPageWikiLink Clinical_trial.
- FDA_Special_Protocol_Assessment wikiPageWikiLink FDA_review_division.
- FDA_Special_Protocol_Assessment wikiPageWikiLink Food_and_Drug_Administration.
- FDA_Special_Protocol_Assessment wikiPageWikiLink New_drug_application.
- FDA_Special_Protocol_Assessment wikiPageWikiLink Phases_of_clinical_research.
- FDA_Special_Protocol_Assessment wikiPageWikiLink Prescription_Drug_User_Fee_Act.
- FDA_Special_Protocol_Assessment wikiPageWikiLink Statistics.
- FDA_Special_Protocol_Assessment wikiPageWikiLinkText "FDA Special Protocol Assessment".
- FDA_Special_Protocol_Assessment wikiPageWikiLinkText "Special Protocol Assessment (SPA)".
- FDA_Special_Protocol_Assessment wikiPageWikiLinkText "Special Protocol Assessment".
- FDA_Special_Protocol_Assessment wikiPageWikiLinkText "Special Protocol Assessments".
- FDA_Special_Protocol_Assessment wikiPageUsesTemplate Template:Cleanup.
- FDA_Special_Protocol_Assessment wikiPageUsesTemplate Template:Context.
- FDA_Special_Protocol_Assessment wikiPageUsesTemplate Template:Empty_section.
- FDA_Special_Protocol_Assessment wikiPageUsesTemplate Template:Medicine-stub.
- FDA_Special_Protocol_Assessment wikiPageUsesTemplate Template:Multiple_issues.
- FDA_Special_Protocol_Assessment wikiPageUsesTemplate Template:Reflist.
- FDA_Special_Protocol_Assessment subject Category:Food_and_Drug_Administration.
- FDA_Special_Protocol_Assessment subject Category:Life_sciences_industry.
- FDA_Special_Protocol_Assessment hypernym Declaration.
- FDA_Special_Protocol_Assessment type Agency.
- FDA_Special_Protocol_Assessment type Organization.
- FDA_Special_Protocol_Assessment type Page.
- FDA_Special_Protocol_Assessment type Organization.
- FDA_Special_Protocol_Assessment comment "A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.Three types of protocols related to PDUFA products are eligible for this special protocol assessment under the PDUFA goals: animal carcinogenicity protocols, final product stability protocols, clinical protocols for phase 3 trials whose data will form the primary basis for an efficacy claim if the trials had been the subject of discussion at an end-of-phase 2/pre-phase 3 meeting with the review division, or in some cases, if the division agrees to such a review because the division is aware of the developmental context in which the protocol is being reviewed and the questions are being answered.The clinical protocols for phase 3 trials can relate to efficacy claims that will be part of an original new drug application (NDA) or Biologic License Application (BLA) or that will be part of an efficacy supplement to an approved NDA or BLA.".
- FDA_Special_Protocol_Assessment label "FDA Special Protocol Assessment".
- FDA_Special_Protocol_Assessment sameAs Q5425274.
- FDA_Special_Protocol_Assessment sameAs m.02v_fkm.
- FDA_Special_Protocol_Assessment sameAs Q5425274.
- FDA_Special_Protocol_Assessment wasDerivedFrom FDA_Special_Protocol_Assessment?oldid=687806564.
- FDA_Special_Protocol_Assessment isPrimaryTopicOf FDA_Special_Protocol_Assessment.