CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
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Stephen Hahn also said the expedited approval process could be even more efficient.
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.
Coronavirus Notebook: Emergency Use Authorization For Blood Plasma Therapy, Pandemic Workloads, US FDA Offices, Rx Mail Deliveries
US FDA issues controversial use emergency authorization for blood plasma therapy while agency officials note workloads nearly double under coronavirus treatment acceleration program. This and more in the Pink Sheet's latest coronavirus update.