US FDA, Sponsors Eye Best Practices For Virtual AdComms
Agency has created a centralized team to help review divisions with virtual advisory committee preparations and is trying to notify sponsors earlier in the review process about the need for a panel; sponsors cite importance of having a back channel of communications so team members can communicate with each other while an AdComm is underway.
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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.