Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting?
Executive SummaryThe device industry has long complained about the lengthy, separate review times required to achieve FDA and CMS clearance. Finally, the two agencies are working together on a pilot program to make this process faster and more efficient. Industry's response: not so fast. Despite the apparent advantages parallel review can offer to product companies, industry has been cautious and slow to respond out of concern for protecting proprietary data and the possible need for more complex clinical studies. Parallel review may represent an example of regulators being ahead of industry in streamlining the regulatory process, and the burden will be on FDA and CMS to demonstrate the true value of this approach.
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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.