During the years of clinical studies required to determine whether a new drug or biologic is safe and effective for human use, FDA staff and product sponsors communicate to discuss various aspects of development. Discussions may cover such topics as clinical trial design, endpoints, data, milestones, and next steps.
As part of PDUFA VI, FDA committed to contracting with an independent third party to assess FDA-sponsor communication practices during the IND stage of new drug/biologic development. The purpose of the assessment was to characterize current communication practices and identify good practices, challenges, and suggestions for improvement. FDA will consider the results of this assessment, together with FDA’s experience, to determine what, if any, refinements in IND stage communication practices are warranted.