US FDA seeks longer, larger studies on CV risks with diabetes drugs
This article was originally published in Scrip
Companies developing new therapies for type 2 diabetes will need to conduct larger, longer studies to rule out an "unacceptable" cardiovascular risk, the US FDA announced on December 17th. The new guidelines are effective immediately for medicines in development as well as those currently under FDAreview, meaning that approval of pending applications could be delayed while companies conduct new studies or re-analyse CV data.
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