FDA moving fast on expedited IND pilot

Competitive challenges from China, Australia, and other countries that have found ways to conduct first-in-human trials efficiently have sparked an extraordinary response from U.S. policymakers. Officials in Washington are exercising muscles that have withered in recent years, collaborating across government agencies and party lines to solve problems that are important and do not pay obvious political dividends. 

Two complementary efforts are underway on separate tracks: one at HHS, centered on FDA; the other in Congress, where FDA’s budget request and next year’s user fee reauthorization are being eyed as vehicles to carry clinical trial modernization legislation over the finish line. ...