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Policy & Legal, Research

August PDUFA Calendar

Ira Loss, EVP Health Care Analyst

20 July 2023

Summary

August will be a busy month for FDA approvals with unofficially 22 applications, including eight novel therapeutics and one new vaccine, with user fee dates. This is the busiest month so far this year. Recent House hearings on the FDA’s budget criticized the agency for the slow pace of manufacturing inspections in China and India. This not-so-subtle nudge may have the desired effect of expediting inspections that have held up some approvals.

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