Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development

The collection of information described in the guidance is intended to provide background information in support of consistent procedures to promote well-managed meetings between OOPD and stakeholders. In some cases, these meetings may represent a critical point in the orphan product development process and may even have an impact on the eventual availability of products for patients with rare diseases and conditions. It is therefore important that these meetings be scheduled within a reasonable time, conducted effectively, and documented where appropriate. The draft guidance describes three collections of information: (1) The submission of a meeting request (for informal and formal meeting), (2) the submission of a meeting package (for formal meetings), and (3) the submission of draft meeting minutes (for formal and certain informal meetings.)

The latest form for Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development expires 2021-05-31 and can be found here.