We are at a time of great change and transition in the FDA. The sitting FDA chief stepped down, just when the 21st Century Cures Act passed into law; PDUFA 6 is up for renewal this year; and the new administration has signaled hiring freezes for government agencies, including the FDA.
While many of the policy and leadership changes in 2017 may not appear to make a day-to-day impact on drug developers at first, these changes can in fact have a profound impact.
To help us understand how 21st Century Cures, PDUFA 6, and leadership changes can affect your development plans, we sit down with Dr. Tim Franson, who is not only YourEncore's Chief Medical Officer, but also Chairman of the Board for The Critical Path Institute, the Immediate Past-President for the USP, and a key contributor to the last few PDUFAs.
