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

Exact Sciences, one of the first companies to volunteer for a pilot program launched in 2011 testing FDA-CMS parallel review, says its experience with the process so far is very positive. Agency officials are planning to review experiences with the program to make improvements.

Parallel FDA and CMS review of new technologies can save manufacturers research costs and reduce the time between FDA approval and national Medicare coverage of a new technology, according to at least one of the companies that has participated in the program.

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 Also see "Calling All Innovators: FDA And CMS Seek Candidates For Parallel Review Pilot" - Medtech Insight, 17 October, 2011.

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