Monday, March 15, 2010

NDA for BYDUREON ( weekly Byetta): FDA issues complete response letter

In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.

Posted via web from Jack's posterous

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