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Discrepancies Between FDA-Required Labeling and Evidence that Payers Cite in Drug Coverage Policies

BACKGROUND: FDA-required labeling summarizes certain data that the FDA relies on in its drug approval process. However, when determining coverage of specialty drugs, health care payers may consider dissimilar evidence. OBJECTIVE: To compare evidence cited by the largest U.S. commercial payers in the...

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Detalles Bibliográficos
Autores principales: Chambers, James D., Pope, Elle F., Wilkinson, Colby L., Neumann, Peter J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Academy of Managed Care Pharmacy 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10397693/
https://www.ncbi.nlm.nih.gov/pubmed/30479201
http://dx.doi.org/10.18553/jmcp.2018.24.12.1240