Remove Drafting Remove Maine Remove Meetings Minutes
article thumbnail

PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog

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.