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AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. government fiscal year runs from October 1 – September 30. As a reminder, the U.S. What’s next? Stay tuned. Featuring previous research by Kedest Tadesse, Kari Oakes and Alec Gaffney.
The court’s decision on June 28 is going to cause a frantic re-evaluation at every regulatory agency in the federal government and in every court in the country. We’re about to find out. Read AgencyIQ’s analysis of the Loper Bright decision ] Unified Agenda: What regulations is the FDA expecting to release through the end of the year?
0910-AH55 December 2023 September 2023 Proposed Rule Clinical Holds in Medical Device Investigations The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. Repeal of this regulation would eliminate an unnecessary policy.
Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. That means at 12:01 on November 18, the government will shut down unless Congress is able to pass either a full budget (unlikely) or a continuing resolution (more likely). the drug and device) of the combination product.
Government shutdown: At present, the FDA has appropriated funding through January 19. While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published.
This proposed rule, if finalized, would implement the pediatric study plans provisions of the FD&C Act, and exercise the authority granted to the Secretary in the provisions of the FD&C Act governing exemptions from pediatric study requirements.
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