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Mid-Cycle Review Meeting for TMB-355 Biologics License Application
2017-08-19
On August 8, 2017, US FDA and TaiMed completed the mid-cycle review meeting for TMB-355 BLA. During the smoothly meeting, FDA stated the necessary follow up actions based on the status of current review and no additional evaluation process is needed for drug safety management. In addition, the planned date for FDA’s late-cycle review meeting is October 31, 2017. FDA informed again that there is no plan to hold an advisory committee meeting to discuss this application and will communicate proposed labeling and postmarketing requirement/commitment requests by October 3, 2017.