FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says

FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says-graysheet: The two agencies formally launched a pilot program for parallel review in 2011, opening up a collaborative effort that allows CMS to begin considering a national Medicare coverage policy for select new technologies as FDA is reviewing the safety and efficacy of a device for regulatory approval. (See "Calling All Innovators: FDA And CMS Seek Candidates For Parallel Review Pilot" — "The Gray Sheet," Oct. 17, 2011.) The goal is to speed up the time it takes a manufacturer to move from product development to securing Medicare reimbursement, a high priority for any device firm looking to gain a marketing edge.