FDA Announces Formal Dispute Resolution Draft Guidance

  • March 12, 2013

By Carrie Rabe, Ph.D.

In today’s Federal Register, the FDA announced the availability of a draft guidance for industry and review staff titled “Formal Dispute Resolution: Appeals Above the Division Level.” This guidance, a revision of the guidance of the same name in February 2000, updates procedures and policies associated with an appeal. Of particular note, the timelines for the review of and interim responses to formal dispute resolutions have been described in greater detail. Procedures for requesting a Type A meeting as part of an appeal are now outlined in the guidance. If a sponsor is requesting a Type A meeting, the FDA has 14 days to grant or deny the meeting under the PDUFA meeting goals. Timelines for scheduling meetings, provision of meeting materials, and involvement of outside experts/advisory panels are also described. In all cases, the 30-day FDA response clock starts after the meeting date. It is important to keep in mind that all timeline reviews listed in the guidance only apply to human drug applications covered under PDUFA.

Carrie Rabe, Ph.D. is a Senior Consultant and Ayesha Adil is a Researcher at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.