JAMA Network Open · 2023 · 12 citations · 4 references
PharmacyPharmaceutical PolicyDrug Approval ProcessesPharmaceutical RegulationRegulatory ScienceAccelerated Approval PathwaysDrug ApprovalDrug DevelopmentDrug EvaluationInvestigational New Drug ApplicationsNew Drug ApplicationsDrug Approval PolicyExpedited Drug DevelopmentExpedited Registration PathwaysFda Drug RegulationFood And Drug Administration ApprovalNew Drug Application DocumentationRegulatory TimelinesTime-to-market Reduction
This cross-sectional study evaluates the duration between application to US Food and Drug Administration (FDA) and approval for new drugs and biologics in the US from 2015 to 2022.
4
Joshua D. Wallach, Alexander C. Egilman, Sanket S. Dhruva et al. · BMJ · 2018 · 72 citations · Full text