Virtual Advisory Committees Are Here, And They Will Take Some Getting Used To
The first virtual US FDA advisory committee review of a drug application was nearly a disaster, but the second proved that the concept can work. Nevertheless, things are going to be very different for sponsors, even when the technology is perfected.
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With two landmark advisory committee meetings coming up, the Pink Sheet reflects on some of the most memorable panel meetings over the last 20 years.
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.
Mallinckrodt’s Terlipressin Narrowly Clears US FDA Panel As Need For Liver Treatment Outweighs Safety Worries
Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate the risk of respiratory failure.