FDA released two guidance documents focusing on communications between the agency and drug developers to make drug development more efficient and to help sponsors avoid costly delays.
A new draft guidance commits to faster responses to requests for end-of-phase meetings between sponsors and the agency, down to two weeks instead of three, while moving up deadlines for related meeting packages. A second document finalized guidance on best practices for timely communication between IND sponsors and the FDA.
The draft guidance on faster responses to requests for meetings replaces two withdrawn guidance documents on the subject, published in 2009 and 2015, and now classifies end-of-phase meetings as their own subtype — with dedicated timelines and scheduling goals.
For PDUFA-regulated products, the document covers formal request procedures and meetings in any format: such as face-to-face conversations, teleconferences or video conferences, as well as purely written responses.