Biopharma companies have a decidedly mixed view of FDA's new post-marketing safety authorities. But for one industry segment-companies concentrating in serving very small patient populations suffering from rare diseases-the new regulatory model is decidedly good for business. What does that mean for the future of Big Pharma?
Centric Health Resources CEO Craig Kephart may be the single biggest fan of the Food & Drug Administration's new post-marketing Risk Evaluation & Mitigation Strategies authority.
Creation of the REMS was "a real tipping point" for Centric, Kephart says, triggering an interest in the St. Louis...