Matches in SemOpenAlex for { <https://semopenalex.org/work/W2055662005> ?p ?o ?g. }
Showing items 1 to 83 of
83
with 100 items per page.
- W2055662005 abstract "I examined the relationship between the Food and Drug Administration's (FDA's) use of special regulatory designations and the frequency with which labels of oncology drugs are revised to explore how the FDA's designation of products relates to product development and refinement.One hundred oncology drugs, designated by the FDA as accelerated approval, priority review, orphan drug, or traditional review, were identified from publicly available information. Drug information for each product was evaluated to assess the rate at which manufacturers revised product labeling. Rates were compared between specially categorized products and traditional review products (e.g., orphan vs nonorphan drugs) to produce revision rate ratios for each special category.Labeling for accelerated approval and priority review products are revised significantly more frequently than are labels for traditional products.Accelerated approval products are approved based on surrogate endpoints; this approval process anticipates subsequent labeling refinement. Priority review products, however, are approved through a process that is ostensibly as rigorous as traditional review. Their higher than expected label revision rate may suggest deficiencies in the FDA's current priority review evaluation processes." @default.
- W2055662005 created "2016-06-24" @default.
- W2055662005 creator A5068255830 @default.
- W2055662005 date "2009-09-01" @default.
- W2055662005 modified "2023-09-24" @default.
- W2055662005 title "Examination of the Relationship Between Oncology Drug Labeling Revision Frequency and FDA Product Categorization" @default.
- W2055662005 doi "https://doi.org/10.2105/ajph.2008.141010" @default.
- W2055662005 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/2724447" @default.
- W2055662005 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/19372515" @default.
- W2055662005 hasPublicationYear "2009" @default.
- W2055662005 type Work @default.
- W2055662005 sameAs 2055662005 @default.
- W2055662005 citedByCount "14" @default.
- W2055662005 countsByYear W20556620052012 @default.
- W2055662005 countsByYear W20556620052013 @default.
- W2055662005 countsByYear W20556620052014 @default.
- W2055662005 countsByYear W20556620052015 @default.
- W2055662005 countsByYear W20556620052016 @default.
- W2055662005 countsByYear W20556620052017 @default.
- W2055662005 countsByYear W20556620052020 @default.
- W2055662005 countsByYear W20556620052022 @default.
- W2055662005 crossrefType "journal-article" @default.
- W2055662005 hasAuthorship W2055662005A5068255830 @default.
- W2055662005 hasBestOaLocation W20556620052 @default.
- W2055662005 hasConcept C112930515 @default.
- W2055662005 hasConcept C126322002 @default.
- W2055662005 hasConcept C141341695 @default.
- W2055662005 hasConcept C17744445 @default.
- W2055662005 hasConcept C177713679 @default.
- W2055662005 hasConcept C199539241 @default.
- W2055662005 hasConcept C203092338 @default.
- W2055662005 hasConcept C2777494893 @default.
- W2055662005 hasConcept C2779913896 @default.
- W2055662005 hasConcept C2780035454 @default.
- W2055662005 hasConcept C3018890749 @default.
- W2055662005 hasConcept C502991105 @default.
- W2055662005 hasConcept C535046627 @default.
- W2055662005 hasConcept C71924100 @default.
- W2055662005 hasConcept C98274493 @default.
- W2055662005 hasConceptScore W2055662005C112930515 @default.
- W2055662005 hasConceptScore W2055662005C126322002 @default.
- W2055662005 hasConceptScore W2055662005C141341695 @default.
- W2055662005 hasConceptScore W2055662005C17744445 @default.
- W2055662005 hasConceptScore W2055662005C177713679 @default.
- W2055662005 hasConceptScore W2055662005C199539241 @default.
- W2055662005 hasConceptScore W2055662005C203092338 @default.
- W2055662005 hasConceptScore W2055662005C2777494893 @default.
- W2055662005 hasConceptScore W2055662005C2779913896 @default.
- W2055662005 hasConceptScore W2055662005C2780035454 @default.
- W2055662005 hasConceptScore W2055662005C3018890749 @default.
- W2055662005 hasConceptScore W2055662005C502991105 @default.
- W2055662005 hasConceptScore W2055662005C535046627 @default.
- W2055662005 hasConceptScore W2055662005C71924100 @default.
- W2055662005 hasConceptScore W2055662005C98274493 @default.
- W2055662005 hasLocation W20556620051 @default.
- W2055662005 hasLocation W20556620052 @default.
- W2055662005 hasLocation W20556620053 @default.
- W2055662005 hasOpenAccess W2055662005 @default.
- W2055662005 hasPrimaryLocation W20556620051 @default.
- W2055662005 hasRelatedWork W103825824 @default.
- W2055662005 hasRelatedWork W1490333997 @default.
- W2055662005 hasRelatedWork W2031089246 @default.
- W2055662005 hasRelatedWork W2033418665 @default.
- W2055662005 hasRelatedWork W2049803422 @default.
- W2055662005 hasRelatedWork W2064161537 @default.
- W2055662005 hasRelatedWork W2079501182 @default.
- W2055662005 hasRelatedWork W2127126387 @default.
- W2055662005 hasRelatedWork W2162978005 @default.
- W2055662005 hasRelatedWork W2181424158 @default.
- W2055662005 hasRelatedWork W2189014650 @default.
- W2055662005 hasRelatedWork W2202917426 @default.
- W2055662005 hasRelatedWork W2263643497 @default.
- W2055662005 hasRelatedWork W2301944771 @default.
- W2055662005 hasRelatedWork W2415293297 @default.
- W2055662005 hasRelatedWork W2535162808 @default.
- W2055662005 hasRelatedWork W2595193106 @default.
- W2055662005 hasRelatedWork W2946766544 @default.
- W2055662005 hasRelatedWork W3123722708 @default.
- W2055662005 hasRelatedWork W3147448311 @default.
- W2055662005 isParatext "false" @default.
- W2055662005 isRetracted "false" @default.
- W2055662005 magId "2055662005" @default.
- W2055662005 workType "article" @default.