FDA Week - 11/29/2019

FDA Draft Guide Aims To Spur Interchangeable Insulin Development

By Beth Wang / November 25, 2019 at 6:36 PM
FDA has reversed its stance that certain comparative clinical studies, including switching studies, are needed to prove interchangeability for insulin products, in a move that could speed access to less expensive insulin products. In a draft guide published Monday (Nov. 25), FDA says it has decided, based on decades of experience with insulin, that certain studies may in fact not be needed. Former FDA chief Scott Gottlieb said the move provides a more efficient pathway for interchangeable insulin products, and...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.