Health Law Advisor

On October 24, 2016 the Food and Drug Administration ("FDA") in conjunction with the Centers for Medicare & Medicaid Services ("CMS") announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally.  Sounds good.  So, why have so few manufacturers taken advantage of the program to date?

Despite its admirable goals, the current Parallel Review Process is too limited in scope ...