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March 3, 2026
A Five-Year Trend Analysis of USFDA Expedited Approvals and Designations for New Drug Applications (2020–2024)
KG
Kailas Vijay Gadekar
RJ
Ramesh Joga
National Institute of Pharmaceutical Education and Research
SY
Sravani Yerram
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Key Points
Expedited approvals for new drug applications have increased over the past five years, indicating regulatory responsiveness.
In 2021, there were 95 new drug applications approved, with a significant percentage receiving expedited designations.
This observational analysis examines pattern shifts in drug approvals via expedited pathways since 2020.
Regulatory bodies may need to adapt as the demand for rapid drug approval increases, indicating evolving healthcare needs.
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Gadekar et al. (Tue,) studied this question.
synapsesocial.com/papers/69a760afc6e9836116a2dace
https://doi.org/https://doi.org/10.1007/s12247-026-10399-z
A Five-Year Trend Analysis of USFDA Expedited Approvals and Designations for New Drug Applications (2020–2024) | Synapse