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This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.” The guidance offers clarification to industry members on the procedures and specifications of formal meetings with the FDA.
This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.” The guidance offers clarification to industry members on the procedures and specifications of formal meetings with the FDA.
There are 5 different meeting types that can take place between the FDA and sponsors or applicants related to the development of biosimilar or interchangeable products:
With the publication of this draft guidance, the FDA has also noted that previous related guidance named “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,” issued in November 2015, is withdrawn.
The FDA is requesting comments on the draft guidance until September 4, 2018.