The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Thanks to new legislative requirements, several reauthorized (or brand new) user fee programs, a recently-updated regulatory agenda and the impending end of the government’s fiscal year, the FDA has at least 131 things (by AgencyIQ’s count) that it either plans to or is required to accomplish by October 1, 2023. Here’s what regulatory professionals need to watch.
Big-picture things to watch in Q3
A rush of things for FDA to do as we approach the end of the fiscal year: The government operates on a Fiscal Year that begins on October 1 each year and ends on September 30.
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