Policy, Research

August PDUFA Calendar

Ira Loss, EVP Health Care Analyst
20 July 2023


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.

Want to learn more? Download the Report.


Public Policy Research
Identify opportunity and risks driven by public policy.

Related Insights

May 2023 PDUFA Calendar

May 2023 PDUFA Calendar

Delays in approvals due to disrupted work schedules at FDA because of the coronavirus...
Read more