Update on CDER, CBER, and CDRH Meetings with Industry

On May 11, 2023, the U.S. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency.  The pandemic had changed the way people live, work and communicate.  Such changes are not limited to personal circumstances.  The pandemic also deeply impacted how industry and the government conduct their operations.  One distinct change has been the rise of conducting meetings over digital platforms.  However, not all changes are forever. FDA has begun to reintroduce in-person meetings.

CDER and CBER

CDER and CBER announced they would resume in-person face-to-face (FTF) industry meetings on February 13, 2023.  Soon after, the Agency announced beginning on March 27, 2023, the FDA generic drug program would resume in-person FTF meetings, but caveated that the in-person FTF meeting option would only be available for pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.

It is also noteworthy that in the March 27 announcement, FDA distinguished between teleconferences and videoconferences despite using the same online platform (e.g., Zoom).  A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video.  Therefore, for planning purposes, applicants should clearly indicate the type of meeting they are requesting.  Applicants should also be aware that FDA has the discretion to decide the format of the meeting (e.g., videoconference, teleconference, or an in-person meeting).

On May 31, 2023, FDA announced that beginning on June 12, 2023, CDER and CBER will expand in-person FTF industry meetings (with a hybrid component), to include requests for Type B End-of-Phase 2 (EOP2), along with the previously announced Type A, BPD Type 1, and Type X meeting requests.  In this announcement, FDA clarified that an FTF meeting “includes in-person meetings and virtual meetings on IT platforms that allow for both audio and visual communication” per the PDUFA VII and BsUFA III commitment letters (see footnote 9 in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, and footnote 2 in Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027).

FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).  Participants with a primary speaking role from FDA and the sponsor side are encouraged to attend meetings in-person while others join virtually.  FDA posted the recommendations for ZoomGov audio and video settings for in-person participants during the hybrid meetings.  FDA also notes that the number of approved in-person meeting requests is limited due to the availability of hybrid conference rooms.  Any meeting requests received before June 12, 2023, or meetings already scheduled, will not be converted to in-person format.

CDRH

As of this blog post, CDRH has not made any official announcements regarding the resumption of in-person meetings.  An estimated timeline for the return of in-person meetings has not been provided by CDRH.

That said, the availability of in-person meetings may differ among the Offices of Health Technology (OHTs).  Based on our experience, some OHTs may offer a meeting where certain members of the review team attend the meeting in person, while others may join the meeting online; others may be entirely online.  However, to the best of our knowledge, CDRH has not granted a meeting where sponsor participants are permitted to join a meeting in-person.

Advisory Committee Meetings

As of this blog post, all Advisory Committee Meetings that FDA has announced will be conducted via an online platform.

Tips for Successful FDA Meetings

Irrespective of the meeting type, it is essential for sponsors to be well-prepared in advance of meeting with FDA.  A successful meeting with FDA hinges on several key factors, including a comprehension of the meeting purpose, an understanding of FDA’s expectations regarding the matters at hand (often conveyed through written feedback before the meeting), the anticipation of and preparation for potential challenges from the review team, and the ability to communicate clearly and effectively.  It is also crucial to maintain a respectful and cooperative demeanor, document the meeting discussion and action items, and promptly address follow-up actions.  By following these tips, industry may be able to foster a productive and constructive engagement with FDA, leading to favorable outcomes for the development of new medical products and a strengthened relationship going forward.