CMS and FDA Announce New Parallel Review Process for Medical Products

On 17 September 2010 the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) issued a notice describing a new, voluntary parallel review process under consideration by these agencies for medical products. Although still in the early stages of its development, it represents a potential opportunity for new technologies, particularly those that would face coverage challenges after FDA approval, to pursue affirmative coverage on a more expedited timetable than currently available. The agencies have provided some details about the parallel review process, and seek comments on a number of aspects of the contemplated parallel review process, which must be submitted by 16 December 2010. The agencies also discuss a small pilot program for the parallel review process.

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