Pink Sheet Podcast: The Upcoming US FDA Commissioner Confirmation Hearing, Sublocade Loses Orphan Designation, Project Orbis Politics
Executive SummaryPink Sheet reporters look ahead to Stephen Hahn's Senate confirmation hearing, review the revocation of Indivior's buprenorphine orphan designation and consider Richard Pazdur's comments about external issues affecting Project Orbis.
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Keeping Track Of Thanksgiving Leftovers: Risdiplam, Artesunate Highlight Glut Of Submissions/Filings
Yes, we know they should be out of the fridge by now, but here are the highlights of submissions and filings during the Thanksgiving week.
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
Stephen Hahn will have over 100 stocks to divest upon becoming FDA commissioner.