FDA's Throckmorton Says There Is No "Systematic Conservatism" On Diabetes Drugs
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Based on the number of investigational new drug applications submitted and meetings requested with FDA, the agency's requirements for studying the cardiovascular safety of diabetes drugs have not had a dramatically negative effect on innovation, despite “allegations” to the contrary, asserted the agency’s deputy director Douglas Throckmorton at the American Diabetes Association meeting.
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