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FDA Corrects Notice on Arthritis Advisory Cmte. Meeting


Federal Register Notice: FDA is correcting a 1/19 Federal Register notice announcing the Arthritis Advisory Committee meeting set to discuss a Celltrion Inc. BLA for a proposed biosimilar to Remicade. The notice contained an incorrect date for individuals requesting oral presentations, and for FDA notifying individuals on their request to speak at the meeting. In FR Doc. 2016-00823, on page 2873, in the third column, in the “Procedure” paragraph, the fourth sentence is corrected to read: “Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 28, 2016.”
On page 2873, in the third column, in the “Procedure” paragraph, the last sentence is corrected to read “The contact person will notify interested persons regarding their request to speak by January 29, 2016.” To view this notice, click here.