CGMP Requirements Apply To Remdesivir In COVID-19 Emergency – But Not To Chloroquine Or HCQ
Among the differences between the emergency use authorizations is that manufacturing quality requirements will apply to Gilead’s remdesivir, while chloroquine and hydroxychloroquine received blanket waivers as part of their EUA from the US FDA.
You may also be interested in...
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.
Under pressure to authorize use of Lilly’s bamlanivimab, the FDA must first weigh efficacy signals and GMP plant remediation progress.
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.