Alkermes CEO Appeals To US FDA’s Woodcock In ‘COVID-19 Pandemic And Depression’ Meeting
Richard Pops has publicly complained about the agency’s review performance during COVID, and Alkermes’ application for a mental health product appears to have been held up because of inspection issues.
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Acting commissioner Janet Woodcock, a candidate for the permanent job, and agency’s career staff also garner the group's compliments.
As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.
US FDA Commissioner Race Shrinks And Widens: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options
White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as FDA Commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.