FDA finalizes PDUFA meeting guidance, expands written responses

These revised guidelines, initially released as a draft on September 22, 2023, incorporate multiple modifications following public feedback.

The final guidelines modify when INTERACT meetings are appropriate, narrowing their use to novel products and development programs that present unique challenges in early development. This change responds to comments from the Biotechnology Innovation Organization (BIO), which asked the FDA to clarify the difference between INTERACT meetings and pre-IND meetings.

The guidelines for Type D meetings remain consistent, with the final guidance providing three additional example scenarios. The FDA can also grant a written response only (WRO) instead of a live meeting for certain meeting types, including B, C, D, and INTERACT meetings.

BIO had encouraged the FDA to outline the criteria applied in determining the appropriateness of WRO, as industry sponsors have experienced an increasing shift towards use of WRO in lieu of teleconference or face-to-face meetings. However, the FDA has not provided the criteria requested.

The final guidance adds pre-sNDA and pre-sBLA to Type B meetings and expands the requirements for meeting requests to include a list of specific objectives or outcomes of the meeting. The guidelines also recommend a 10-question cap with a numbering convention for meeting requests.

The new guidelines do not apply to Abbreviated New Drug Applications (ANDAs), biosimilar applications, or medical devices.

According to the final guidance, the FDA can substitute a WRO for a live meeting “regardless of format requested” for certain meeting types.