USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products

The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft guide on "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" today (22 September 2023).

This guidance outlines FDA's recommendations for formal meetings between the agency and sponsors or applicants relating to drug and biological drug product development and review.

This guidance defines formal meetings as those that are requested by sponsors or applicants and can be conducted in any format such as face-to-face, virtual (video conference), teleconference, or written responses only (WRO).

There are various types, formats, and timelines associated with those requests described in this draft guidance, and it also provides the industry with the necessary information to prepare a complete meeting request and background package so the meeting can be conducted successfully in order to gain useful feedback for the product development process.

There are six types of formal meetings under PDUFA that occur between requesters and FDA staff:

1. Type A (Eg: Dispute resolution meetings, Meetings to discuss clinical holds)

2. Type B (Eg: pre-IND, NDA/BLA meetings, Pre-emergency use authorization meetings)

3. Type B (end of phase (EOP)), (Eg: Certain end-of-phase 1 meetings, End-of-phase 2 (i.e., pre-phase 3) meetings)

4. Type C (Any meeting other than a Type A, Type B, Type B (EOP), Type D, or INTERACT meeting)

5. Type D (Eg: Narrow set of issues, A follow-up question that raises a new issue after a formal meeting)

6. Initial Targeted Engagement for Regulatory Advice on CDER and CBER Products (INTERACT)- For novel products and development programs.

In order for the FDA to evaluate the potential utility of the meeting and identify the FDA staff involved in the proposed agenda items, the meeting request should include adequate information.

This guidance does not apply to abbreviated new drug applications, biosimilar biological product applications, or submissions for medical devices.

There was another draft guidance that was released today by CDER & CBER "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications" which aims to inform applicants of FDA's intention to use alternative tools in assessing manufacturing facilities identified in marketing applications (a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these applications).

The following alternative tools were used during the public health emergency:

• Requesting records and other information, pursuant to section 704(a)(4) of the FD&C Act (21 U.S.C. 374(a)(4)), directly from facilities and other entities subject to inspection

• Performing remote interactive evaluations (RIEs) (e.g., remote livestreaming video of operations, teleconferences, screen sharing)

• Requesting existing inspection reports and other information from trusted foreign regulatory partners through mutual recognition agreements and other agreements