FDA Issues Final Guidance to Industry, “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products”

U.S. Food and Drug Administration issued a final guidance for industry: “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products.”  The final guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of proposed biosimilar, including interchangeable biosimilar, products regulated by FDA.