10/24/2023
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On September 21, 2023, the Food and Drug Administration (FDA) released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products” to advise on formal meetings between the agency and sponsors or applicants involved in the development and review of investigational products. The new draft guidance replaces the previous version issued in December 2017.
The draft guidance elaborates on the principles of effective meeting management practices and presents standardized procedures for facilitating formal meetings. While the guidance primarily focuses on meetings related to product development and review, the procedures may be expanded to other meetings beyond the application process. The guidance describes standardized procedures for the following:
Meeting Requests
Preparation (i.e. meeting package)
Scheduling
Meeting Conduct
Documentation (i.e. meeting minutes)
In summary, the new draft guidance offers valuable insights by providing a structured framework for applicants to engage with the FDA during the approval process. It helps applicants understand the processes, expectations, and documentation required, ultimately facilitating more effective interactions, and improving the chances of regulatory success. Applicants who adhere to the guidance's recommendations can streamline their interactions with regulatory agencies, ensuring that their products are developed and brought to market in a compliant and efficient manner.
Click here to leave comments on the new draft guidance. All comments for consideration are due by December 21, 2023.
-The Clinical Pathways Team
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