RE: The real news10 Nov 2020 07:44
From a 2009 guidance note: "Guidance for Industry
Formal Meetings Between the FDA and Sponsors or
Applicants" I think type A meeting just means it is the meeting type for SPA request, last bullet point. Type B, C meetings discuss other issues. Asking for approval to use the drug before P3 complete shows confidence. I did ask a similar question a few months back - something like I thin - can P3 data from old study be used to speed up shorten new P3 trial.
"III. MEETING TYPES2
There are three types of meetings that occur between sponsors or applicants and FDA staff: Type
A, Type B, and Type C. Each meeting type is subject to different procedures, as described
below.
A. Type A Meeting
A Type A meeting is a meeting needed to help an otherwise stalled product development
program proceed. Examples of a Type A meeting include:
• Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in
the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level3
• Meetings to discuss clinical holds in which a response to hold issues has been submitted,
but the FDA and the sponsor or applicant agree that the development is stalled and a new
path forward should be discussed
• Special protocol assessment meetings that are requested by sponsors or applicants after
receipt of FDA evaluation of protocols under the special protocol assessment procedures
as described in the guidance for industry Special Protocol Assessment"