parallel review pilot
FDA, CMS Make Parallel Review Program Permanent; Will Device and Diagnostic Companies Engage?
Premium
After a five-year pilot, only one company has successfully taken a test through parallel review, but there is growing industry interest.
Foundation Medicine Pursuing Parallel Review by FDA, CMS for FoundationOne
The company hopes to simultaneously achieve premarket FDA approval and a national coverage determination from CMS for its NGS cancer panel.
With Top-line Deep-C Trial Data, Exact Sciences Gears Up for FDA and CMS Submissions for Cologuard
Premium
Originally published April 23.
Originally published April 2.
FDA/CMS Parallel Review of Medical Products Limited Only by Sponsors' Reluctance, CMS Official Says
Premium
Originally published Dec. 5.
By Turna Ray