Biosimilar User Fee Collections Climb; Application Growth Less Clear
FDA plans to send out 57 invoices for annual biosimilar product development fees in fiscal year 2016, 10 more than were sent last year, but agency remains mum on how many 351(k) submissions it expects.
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Interactive chart of growing 351(k) pipeline shows that while Phase III is dominated by big players, pure-play biosimilar companies are beginning to emerge.
Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.
The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.