Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings
More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.
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Oncology division officials summarize the agreements and discussions reached during formal meetings so there are no misunderstandings later. Sponsors want the practice used more widely by the FDA.
A Type A meeting was held in-person with a virtual contingent, the FDA clarified to the Pink Sheet. Several other meeting requests received were eligible, but did not seek an in-person session.
In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.