Warning Letter Roundup & Recap – May 2022
No medtech-related warning letters were released by the US FDA last month.
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Zelnecirnon (RPT193), in Phase IIb for atopic dermatitis and Phase IIa for asthma, may not have caused the case of liver failure cited in the hold but the pause may impede a crucial data readout.
Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.
VC funding will remain challenging for many in the health care industry, Silicon Valley Bank’s market manager Milo Bissin told attendees at the recent DHIS West conference. Companies focusing on promising areas such as AI-powered technologies, women’s health and value-based care likely have the best chances to draw investors’ attention.