PDUFA VII Communications: Earlier PMR Talks, Formal Meeting Additions
Sponsors will receive additional agency interactions through the formal meeting process, as well as an option to ask clarifying questions later.
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With a PRIME designation also in hand for isaralgagene civaparvovec, Sangamo still needs to secure a partner before beginning its pivotal trial, which importantly will not have to include a head-to-head comparison with enzyme replacement therapies.
FDA data suggests sponsors still seem enamored with virtual meetings, even as the FDA expands the sessions eligible for in-person attendance.
At least one sponsor has been recording meetings for several years, suggesting others could receive permission, but the decision comes with risks as well as benefits. As the agency again expands options for in-person meetings, sponsors may want to reflect on what works best for them.