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FDA Returns to In-Person Meetings Starting 12 June
(Thursday, June 1, 2023) After a hiatus of more than 3 years, the face-to-face (FTF) meetings between FDA and industry applicants will start in about 2 weeks. However, these meetings will not be like the widely attended meetings of the pre-pandemic years, but for selective types of discussions and on a hybrid format. Meetings with the FDA are a critical tool for the industry to resolve critical issues during the development of new drugs and biologics. These meetings have formed the cornerstone of FDA’s transparency initiatives for the last three decades. However, these meetings also consume a lot of resources at the FDA. While FDA encourages sponsors to meet with it and has written more than 14 guidance documents on how to for the meetings in the last 20 years, the sheer volume of the in-person meetings had overwhelmed FDA in the pre-pandemic years. To deal with the excessive demands for FTF, FDA started two practices to address meeting requests. First, about 10 years ago, FDA started written-response-only (WRO) in response to meeting requests, whereby in lieu of meeting the sponsors, FDA would respond in writing to their questions presented in the meeting information package. Pre-2020, about half of the meeting requests resulted in WROs, to the agony of the industry who preferred live discussions with the FDA. Second, FDA granted about 40% of the meeting requests as virtual meetings via telephone conference calls. Although teleconferences cannot truly replace in-person meetings, they certainly are better than the WRO. Many FTF also included some attendees on both the FDA and sponsor side attending via telephone conference calls. The pandemic and the resulting remote work schedules made teleconferences the only option available for FDA-industry meetings. And FDA got quite comfortable with the logistical convenience of the teleconference meetings with several senior FDA leaders hinting that the remote meetings are here to stay. However, seeing the generally negative reaction from the stakeholders to virtual audio-only meetings, FDA has been rethinking. This week’s announcement is a step in that direction. Starting June 12, FDA would start granting in-person meetings for critical meetings such as End-of-Phase 2 (EOP2) along with Type A, and BPD Type 1 and Type X meetings. All other meetings would continue to be via audio only Zoom meetings. The new FTF meetings will allow limited participants on site at the FDA campus in Maryland, with all others attending via video links. This ‘hybrid’ format will look like the one that existing pre-pandemic where those with primary speaking roles, both at the FDA and the sponsor, will be physically present at the conference rooms on FDA campus, while the rest attending virtually. This policy for FTF meetings will apply to new meeting requests received after June 12, 2023, and not for the meetings already granted before that date as virtual meetings. Industry should be happy with this announcement. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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