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Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance

Posted 02 January 2018 | By Zachary Brennan 

Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance

Know the difference between a Type A, Type B and Type C meeting with the US Food and Drug Administration (FDA)? New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect.

The 20-page draft explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how FDA can respond, how long the agency can take to respond, and how the sponsor and FDA can go about conducting efficient, consistent, timely and effective meetings.

The draft also discusses premeeting preparation, the contents of a meeting package, what kind of preliminary responses (which FDA says, “should not be construed as final unless there is agreement between the requester and the FDA that additional discussion is not necessary”), rescheduling and canceling meetings, and meeting conduct and minutes.

In terms of meeting denials, FDA explains: “For example, a meeting can be denied because it is premature for the stage of product development or because the meeting package does not provide an adequate basis for the meeting discussion. Thus, the FDA will generally deny requests for Type A meetings and Type C meetings to discuss the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval that do not include an adequate meeting package in the original request.”

Meeting goal dates and timelines were also outlined in an appendix:
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The draft comes as stakeholders have recently weighed in on draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors, and back in 2015, FDA finalized guidance on formal meetings with biosimilar sponsors.

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: Draft Guidance for Industry


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