RE: out 4 now, back next year22 Nov 2021 10:07
FDA has committed to providing a scheduled date for 90 percent of post-CRL meetings within
10 calendar days10 of receipt11 of a written request.12 FDA has further committed to conducting
90 percent of post-CRL meetings held on an FDA-proposed date within 30 days of receipt of a
written request.13 In the event FDA proposes a post-CRL meeting date within 30 days of receipt
of a written request, but the meeting is ultimately scheduled outside of the 30-day window at the
applicant’s request, FDA will consider its goal of conducting the meeting within 30 days of
receipt of a written request met.