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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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Update on CDER, CBER, and CDRH Meetings with Industry

FDA Law Blog

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. An estimated timeline for the return of in-person meetings has not been provided by CDRH. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency.