Posted by Michael Wonder on 03 Jun 2018
FDA chief outlines new ways to speed cancer drug approvals
2 June 2018 - The U.S. FDA is taking steps to streamline the approval process for cancer drugs, reviewing clinical trial data up front to make sure applications companies submit are complete.
The new approach, outlined on Saturday in a speech by FDA commissioner Dr. Scott Gottlieb at the American Society of Clinical Oncology (ASCO) meeting in Chicago, is part of an effort to remove regulatory barriers that drag out reviews of promising new cancer treatments.
The new review process, which Gottlieb called a "real-time oncology review," is already being piloted in a number of applications for expanded use of already approved cancer drugs.
