The table below provides a comprehensive timeline for each of the meeting types. [1,3]
Meeting Type | FDA Response to sponsor (days) | FDA Receipt of Meeting Package | FDA Preliminary Reponses due to sponsor (if applicable) | Sponsor response to the FDA’s preliminary responses (if applicable) | FDA Scheduled Meeting date (days from receipt of request) | FDA Meeting Minutes to sponsor (if applicable) |
A | 14 | With meeting request | Latest - 2 days before the meeting | Within 30 days | 30 days after meeting. With WRO, the WRO will serve as meeting minutes from FDA. | |
B | 21 | Latest - 30 days before meeting | Latest - 2 days before the meeting | Within 60 days | ||
B (EOP*) | 14 | Latest - 50 days before meeting | Latest - 5 days before the meeting | Latest - 3 days after receiving preliminary responses | Within 70 days | |
C | 21 | Latest - 47 days before meeting | Latest - 5 days before the meeting | Latest - 3 days after receiving preliminary responses | ||
D | 14 | With meeting request | No later than 5 days before meeting | Latest - 3 days after receiving preliminary responses | Within 50 days | |
INTERACT | 21 | With meeting request | No later than 5 days before meeting | Latest - 3 days after receiving preliminary responses | Within 75 days | Preliminary responses will be annotated and resent within 30 calendar days if advice provided changes as a result of the meeting. With WRO, the WRO will serve as meeting minutes from FDA. |
*EOP = End of Phase [1,3]