Type A Meeting Meaning Type A Meeting
87
88 A Type A meeting is a meeting that is necessary for an otherwise stalled product development
89 program to proceed (a critical path meeting) or to address an important safety issue. Examples
90 of a Type A meeting include:
91
92 Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in
93 the draft guidance for industry and review staff Formal Dispute Resolution: Appeals
94 Above the Division Level5
95
96 Meetings to discuss clinical holds: (1) in which the requester seeks input on how to
97 address the hold issues; or (2) in which a response to hold issues has been submitted, and
98 reviewed by the FDA, but the FDA and the requester agree that the development is
99 stalled and a new path forward should be discussed
100
101 Special protocol assessment meetings that are requested after receipt of an FDA letter in
102 response to protocols submitted under the special protocol assessment procedures as
103 described in the guidance for industry Special Protocol Assessment6
104
105 Post-action meetings requested within 3 months after an FDA regulatory action other
106 than an approval (i.e., issuance of a complete response letter)