Our Expectations with Type A meetingType 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 2 The meeting types and goal dates were negotiated under PDUFA and apply to formal meetings between