FDA Clarifies Meeting Types and Other Details in a New Guidance on Meetings
(Thursday, September 28, 2023) Meeting the FDA is unquestionably the most important resource available to sponsors/developers of new drugs and biologics. Over the last 30 years, these meetings have evolved into complex procedures. Their potential outcomes depend not on just what you ask but how you ask and when you ask the FDA about a particular issue related to a given product development program. FDA’s new guidance tries to consolidate the various guidance documents it has released over the last 25 years about the process and logistics of meetings with it. What it lacks in terms of surprises or new information, it makes up by summarizing the overall process of meeting with the FDA across almost all the potential reasons one might want to meet with the FDA. Over the last 25 years, the FDA has released more than 20 Guidance Documents prior to this new one, describing the various ways for meeting with the reviewers based on the type of discussion, the type of product, and the nature of the specific questions one wants to ask the reviewers. These guidance documents have been used by the regulated industry extensively and have led to the exponential growth of FDA-industry interactions over the last two decades. There was a time, in the pre-pandemic era when the FDA campus could be hosting tens of meetings with sponsors at any given time of the workday. The pandemic made it impossible to meet the FDA in person, and online meetings and written responses became the only way to “meet” the FDA. This new guidance document cements the anecdote that the pre-pandemic meeting format is gone for good. There are 6 different meeting types each with a specific purpose, format, and logistics. The Guidance Document introduces two new terms for meetings; the Type B (EOP) and the Type D, which seem to be a subset of what had always existed within the Type B and Type C meetings, respectively. The instructions for the meeting process remain unchanged. The requesters must be very familiar with the guidance documents and other information available on the FDA website relevant to their products and the topics they want to discuss with the FDA, prior to requesting a meeting. The meeting requests must contain reasonable background information allowing the FDA to decide on whether to grant the meeting, and the chosen format (virtual, in-person, or written response). The meeting request must be formally submitted to the FDA electronically. Each meeting request and various milestones for these meetings have defined timelines, which are similar to what has existed over the years. It is obvious from the guidance document that in-person or even video meetings would be rare; most meeting requests would lead to “Written Responses Only” or teleconference at best, in line with the trends observed over the last 5 years. FDA’s decision about a given format for the meeting can be rarely challenged. Sponsors/requesters would need to prepare the meeting requests diligently to justify why a meeting is the only way feedback can be obtained from the FDA for a critical aspect of their development program. It is also obvious that the FDA has greatly expanded its internal project management (regulatory project management, RPM) departments related to dealing with meeting requests so the reviewers would only be involved if the RPM agreed with the need for a meeting. For those who have held meetings with the FDA over the last 10 years, there is nothing new, and for the newbies to this process, this is the most important first Guidance Document to study. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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