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Guidance on Biosimilar Sponsor Formal Meetings


Federal Register Notice: FDA is making available a guidance for industry entitled Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants. It provides recommendations on formal meetings related to the development and review of biosimilar biological products regulated by CDER and CBER. The guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting packages to FDA for biosimilar biological products. It finalizes a 4/1/13 draft guidance. To download this guidance, click here. To view this notice, click here.