OTP Requests for Clarification

Requests for Clarification to Formal Meetings

A request for clarification may be sought after a Type A, B, C, D or INTERACT meeting to ensure the requestor’s understanding of FDA feedback provided in a preliminary response (if the formal meeting was canceled), meeting summary, or written response only (WRO) issued by OTP. 

The ‘Request for Clarification’ should only include questions of a clarifying nature (i.e., to confirm something in meeting summary or in a WRO issued by OTP). OTP will assess if the request is in scope before initiating review. New issues or proposals in response to OTP’s feedback may not be submitted as a Request for Clarification. If OTP determines that the Request for Clarification is not within the scope, they may ask the sponsor to request a new formal meeting with OTP to address the issue.

For sponsors considering whether to cancel a scheduled formal meeting with FDA following receipt of a preliminary response, if any clarifications are needed, it may be beneficial to proceed with the formal meeting rather than canceling the meeting and submitting a Request for Clarification, depending on the nature and complexity of the clarification(s) needed.

Submission of Requests for Clarification to OTP

The sponsor should submit the Request for Clarification in writing, as an amendment to the original meeting request. The sponsor should indicate in the cover letter that this is a request for clarification for the OTP communication type (meeting summary, preliminary response due to meeting cancellation, or WRO), the date of OTP communication, and the assigned CBER submission tracking number (PS, IND, BLA, BLA supplement) and/or Meeting ID number.

OTP does not send an acknowledgement email or letter following OTP’s receipt of a Request for Clarification. However, by the timelines described in the table below, OTP will send the written response, referencing the previous meeting, or reasons for denial (if request is out-of-scope).

Table 10: Timelines for Requests for Clarification

Sponsor’s Request for Clarification*	20 days from receipt of the preliminary response (if the formal meeting was canceled), meeting summary, or WRO
OTP Response Due to Sponsor (if criteria for Request have been met)*	20 days from receipt of clarifying questions