An applicant may request a 30-minute teleconference within ten business days after
FDA issues a first-cycle review CR letter to discuss the deficiencies noted in the
letter. The request for a teleconference must be submitted in writing to the ANDA
file and appropriately identified on its cover page as a “Post Complete Response
Teleconference Meeting Request.”
The request should include a list of specific written questions for discussion. The
scope of the questions should be limited to the content of FDA’s CR letter. Priority
for such teleconferences will be given to expedited and first major amendment
applications and other applications as detailed in the Commitment Letter.
