Need For Advanced Manufacturing Technologies A ‘Great Learning’ From The Pandemic, CBER’s Marks Says
COVID-19 highlighted limited domestic capacity and need for more flexibility, agility and reliability in manufacturing processes, says FDA biologics center director Peter Marks; he also discussed differences in data review for vaccine BLAs relative to EUAs.
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US FDA veterans offered varying opinions as to the benefits and risks of the CBER director taking on a more hands-on role in reviewing Pfizer’s COVID-19 vaccine. The move was called unusual, but not inappropriate; some said it should be monitored closely to ensure review staff’s judgements are not pushed aside.
Acting FDA Commissioner Janet Woodcock says stability studies are ongoing and that states shouldn’t get rid of expiring inventory yet.
CRS poses series of questions about how a new federal agency tasked with speeding translational research for treating high-impact diseases would work, including potential downsides and whether it would duplicate government programs already in place.