The Food and Drug Administration (FDA) warned Abbott Laboratories' (ABT) diabetes unit about manufacturing violations involving the company's blood-glucose-monitoring systems, according to a report published on NASDAQ.com...
Tag: FDA
GlaxoSmithKline confirmed that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow the diabetes drug Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions...
Amylin Pharmaceuticals Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM).
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. The companies view this response as a positive step forward...