On June 4, 2018, FDA announced the availability of a new draft guidance on formal meetings with FDA concerning the development and review of biosimilar or interchangeable biological products. The draft guidance, titled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products,” is available here. FDA also announced that its previous (November 2015) guidance on “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,” has been withdrawn.
FDA explains in its announcement that the new draft guidance “discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting formal meetings between FDA and sponsors or applicants of BsUFA products,” and, “when finalized, will represent the current thinking of FDA on formal meetings between the FDA and sponsors or applicants of BsUFA products.”
Comments on the draft guidance are due by September 4, 2018.