Stability Genius: How CMC Section Of COVID-19 Vaccine Guidance Speeds EUAs Safely
By focusing on short-term stability, US FDA paves way for quicker emergency use authorization without compromising on quality.
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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.
The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.