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

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.