Analysis of FDA approvals, delays and denials of new drug applications, 2013-2023

Timely approval of New Molecular Entities (NMEs) is central to patient access and innovation. We analysed small molecule NME submissions reviewed by the US Food and Drug Administration (FDA) between 2013 and 2023. New Drug Applications (NDAs) were classified as first-cycle approvals, delayed approvals after one or more Complete Response Letters (CRLs), or non-approvals. Data from FDA databases and review records were analysed to characterise outcomes, timelines, and the reasons for CRLs. Patterns were compared with earlier benchmarks. The analysis highlights both progress and persistent challenges in FDA review efficiency, underlining the importance of robust trial design, appropriate dose selection, and manufacturing readiness, alongside continued oversight of post-approval evidence generation and confirmatory obligations for drugs approved under expedited pathways.