PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information
FDA Law Blog
JUNE 26, 2024
30 minutes or one hour) and type of meeting (i.e., In addition, the applicant is required to provide a draft agenda with an estimated time for each item on the agenda. The agenda at this point is usually quite general, with specifics added after receipt of FDA’s written feedback ahead of the meeting.
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