Meetings for approved products are handled similarly to other formal meetings and scheduled as Type B, or C meetings as needed.
Submission of meeting request
Meeting requests can be submitted to the BLA as Product Correspondence, if ongoing studies are not being carried out under an IND.
Pre-sBLA (Type B) for efficacy
For BLAs associated with ongoing clinical studies under IND, pre-BLA meeting requests for an efficacy supplement can be submitted to the associated IND. If there is no associated IND, then a pre-BLA meeting request can be submitted in a product correspondence. Please review the pre-BLA meeting section under IND meetings.
Courtesy emails to the Regulatory Project Manager (RPM) for the BLA and to OTATRPMS@fda.hhs.gov regarding submission of the meeting request are greatly appreciated.
OTAT attempts to honor the requested format. OTAT schedules efficacy supplement pre-BLA meetings for 60 minutes.
Type C meeting requests are evaluated on a case-by-case basis to determine if a meeting is needed or if the feedback the sponsor is seeking can be provided during review of the BLA supplement. When granted, Type C meetings are typically Written Response Only (WRO). Please refer to Type C meetings discussed under IND meetings.