FDA Seeks To Standardize Breakthrough Pathway, Urges Sponsors To Talk Early With Payers

December 1, 2014 at 3:37 PM
FDA is looking to standardize how it chooses drugs for the breakthrough approval pathway, and an early analysis of the handful of drugs chosen shows the most important criteria is that the therapy show a "spectacular advance in the field" over the typical improvement in drug development, drug center chief Janet Woodcock recently told an industry audience. Drugs selected also tended to have a genetic component and had marginally more people enrolled in trials than those rejected, she said. Woodcock...

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.