OTP Meetings for Approved Products

Meetings for approved products are handled similarly to other formal meetings and scheduled as Type B, C, or D 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-BLA Supplements (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, under the BLA. Please review the Pre-BLA Meetings section under IND meetings.

OTP schedules efficacy supplement Pre-BLA meetings for 60 minutes.

Type C

Please refer to Type C Meetings discussed under IND meetings.

Type D 

Type D Meeting requests are granted if the criteria for the meeting type are met.  Please refer to Type D Meetings discussed under IND meetings.