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FDA Updates its SOP for Meetings with Sponsors
(Thursday, July 25, 2024) There are more than 20 FDA guidance documents on various types of FDA meetings with the sponsors which can be confusing because similar information is repeated across multiple documents. On the other hand, the FDA’s internal processes for managing meeting requests highlight a unified FDA approach to different meetings. How does the FDA staff process a meeting request, what criteria are used to accept or deny a meeting request, which meeting requests usually lead to written response only, and many such useful nuggets of information are available in the FDA’s internal SOPP (Standard Operating Policy and Procedures) on meetings with sponsors. Meetings with the FDA are one of the most valuable resources available to sponsors. While the FDA has published numerous guidance documents to help the regulated industry request and prepare for meetings with its staff, the constantly evolving meeting names, new jargon for describing the purpose of meetings, the seemingly myriad types of meetings for individual types of regulated products, and other such nuances could be confusing for companies looking to discuss issues with the FDA, particularly for small and medium-sized companies with access to limited regulatory resources. The FDA SOPP for meetings with sponsors is a great resource for such companies, in particular, and for everyone in general. The SOPP provides insight into how the FDA receives, reviews, and decides on different types of meeting requests. The document walks the reader through the internal FDA processes from receipt and review of the original request to internal meetings to prepare the preliminary responses, logistics of the meeting, meeting attendees, meeting notes, and follow-up. It describes the criteria for in-person, virtual, or Zoom meetings, and the criteria for granting written responses only. It provides specific considerations for biosimilar meetings, PDUFA or GDUFA meetings, above the beyond the standard procedures. The SOPP can help answer some common questions regarding meetings with the FDA. The SOPP discusses procedures for the Center for Biologics (CBER), but the processes described herein are essentially identical to those followed by the Center for Drugs (CDER) and the Center for Devices (CDRH). This is the 14th amendment in the SOPP since its original creation almost 15 years ago. The SOPPs provide a great internal perspective to outside parties and could help plan better and more productive meetings with the FDA. 
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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