Food and Drug Administration's Best Practices for Food and Drug Administration Communication With Interested Parties: Draft Report for Public Comment; Availability

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Best Practices for FDA Communication with Interested Parties: Draft Report for Public Comment." This draft report and implementation plan respond to the Consolidated Appropriations Act of 2023, which directs FDA to issue a report on FDA's practices for broadly communicating with external interested parties and a plan for implementation of such best practices. In addition, FDA is to conduct a review of the types and methods of public communication that FDA uses to communicate and interact with medical product sponsors and other external interested parties; identify best practices for the efficient development, issuance, and use of such communications; and develop a plan for implementation of best practices for these communications. As directed, FDA is publishing and soliciting feedback on this draft report and implementation plan.