FDA releases draft guidance on formal meetings between the FDA and sponsors or applicants of PDUFA products

The Food and Drug Administration (FDA) has released draft guidance providing recommendations to industry on formal meetings between the FDA and sponsors or applicants relating to the development and review of drug or biological drug products regulated by the Centre for Drug Evaluation and Research (CDER) and the Centre for Biologics Evaluation and Research (CBER). The guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or submissions for medical devices.

The draft guidance discusses how sponsors can submit a formal request for a meeting, which can be teleconference/videoconferences, face-to-face meetings or written responses only. The guidance explains what sponsors should include in their request for a meeting, how the FDA can respond, how long the agency can take to respond, and how the sponsor and the FDA can conduct efficient, consistent, effective and timely meetings. The guidance discusses the principles of good meeting management practices and the general principles may be extended to other non-application-related meetings with external constituents.

The draft also contains details regarding pre-meeting preparation, the contents of a meeting package, preliminary responses, rescheduling, cancelling meetings, meeting conduct and minutes.

To read the FDA draft guidance on formal meetings between the FDA and sponsors or applicants of PDUFA products, please click here.