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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Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.
US FDA’s Oncology Center of Excellence is eager to pilot test ‘Drug Development Snapshots’ as a potential tool to optimize communication for drugs receiving the Breakthrough Therapy Designation. That may be an early next step in the effort to enhance the expedited pathway.
Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.