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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Scott Gottlieb says that some meetings should remain in-person, but with virtual options proven effective, the FDA could offer more opportunities to talk to sponsors.
Complete Response Letters: US FDA Tells Congress Broader Disclosures To Sponsors Could Be ‘Chilling’
A lengthy hearing that addressed everything from Aduhelm to advanced manufacturing serves as the formal kick off of the user fee reauthorization season and offers a preview of many possible FDA reforms that House members could seek to include in the legislation.
Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.