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FDA Issues Draft Guidance on Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products and Classification Categories for Certain Supplements under BsUFA III | Goodwin
In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and.
Product development
Drug administration
Certain supplements
Biosimilar initial advisory
Biological product development
Biosimilar user fee amendments
Safety information
Additional indication
Without new data sets
With new data sets
Does not contain an up to date agreed
With efficacy data sets
Initial determination
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