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FDA Seeks Participants for Biosimilar Act Reauthorization


Federal Register Notice: FDA is requesting that industry trade associations, whose members include drug companies currently engaged in developing or manufacturing biosimilar biological products in the U.S., or drug companies intending to engage in these activities during the period of FY 2018-2022, notify the agency of their intent to participate in industry stakeholder meetings in support of timely reauthorization of the Biosimilar User Fee Act of 2012. Its statutory authority expires at the end of 9/2017. Participants should submit notification of intention to participate by 10/30. To view this notice, click here.