Starting February 2023, the CDER and CBER staff will be transitioning to a hybrid workplace, with staff returning to work at the White Oak campus (on-site) for a portion of their time. This transition will enable FTF formal meetings between FDA and industry to be restarted.
CDER and CBER will restart in-person, face-to-face industry meetings. Sponsor receives a WRO in response to a pre-IND meeting request and believes a face-to-face meeting would be most valuable. Sponsor may submit a follow-up correspondence to the FDA justifying the need for a face-to-face meeting.
These meetings allow Sponsors to learn the FDA’s current thinking on a specific topic and to amend their development program based on FDA’s recommendations appropriately.
The PDUFA VII and BsUFA III commitment letters provide an update to the definition of face-to-face formal meetings with industry. This update clarifies that a face-to-face meeting “includes in-person meetings and virtual meetings on IT platforms that allow for both audio and visual communication.
To avoid overcrowding in the conference rooms, FDA will focus on having only core participants with a primary speaking role in-person while others join virtually.
The PDUFA VII Commitment Letter outlines several additions and enhancements to existing formal PDUFA meetings and related procedures:
- Type D Meetings: Is focused on a “narrow set of issues.” By this, FDA means these will typically be granted for discussion of one or maybe two issues (but no more than that). The target is for the FDA to respond to Type D meeting requests within 14 days and schedule meetings within 50 days.
- INTERACT Meetings: Focus on unique challenges and novel questions for CDER and CBER products for which existing FDA guidance or other information is available. These meetings provide FDA input on issues early in development, prior to IND filing and typically before the request for a pre-IND meeting. FDA will respond to an INTERACT meeting request within 21 days, and meetings will be scheduled within 75 days.
- Procedural Changes and Clarifications: The FDA recommends that written meeting requests state the purpose of the meeting, as well as indicate the Sponsor’s preference for a written response (WRO) from the FDA, or an in-person face-to-face, teleconference, or virtual meeting that enables audiovisual communication.
- Challenging a WRO Response: Receives a WRO in response to a pre-IND meeting request the Sponsor may submit a follow-up correspondence to the FDA justifying the need for a face-to-face meeting.
- Requesting Post-Meeting Clarification: Sponsors who wish to clarify questions or confirm feedback in meeting minutes or WROs issued by the FDA.
- Within 20 days of receipt of the Sponsor’s clarifying questions, FDA will respond in writing, referencing the original meeting minutes or WRO.
- Updated Guidance and Opportunities to Contribute: The FDA plans to issue a revised version of the existing draft guidance, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” by September 30, 2023.
- Type A meetings: Are “critical path” meetings that are reserved for otherwise stalled drug development programs to enable the development program to proceed.
- Type B meetings: Are pre-IND, End of Phase (EOP) 1, and EOP2/pre-phase three milestone meetings. Other Type B meetings include those occurring outside the context of a marketing application to discuss REMS or post-marketing requirements.
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.