This article was originally published in The Gray Sheet
Epigenomics, RainDance, and Brightree name new leadership, and more personnel news from around the industry.
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Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.
As the global biopharma industry attempts to understand the implications of the US Inflation Reduction Act, South Korea's biopharma industry is pressing its government to come up with "bold and rapid" additional measures to reduce the possible negative impact of the legislation and other US policies with international implications, and to support the sector amid generally rising global competition.
OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.