By Jessica Bylander
While the device industry has been anything but shy with its criticism of the FDA's pre-market product clearance program of late, there remains an equally important additional hurdle after FDA...
Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting?
The 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.
More from Archive
More from In Vivo
• By
From billion-dollar COVID antibody to a strategic reset, Marianne De Backer is navigating Vir's comeback through pipeline focus and disciplined leadership.
• By
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
• By
A Q&A with DeAnn Smith, partner and co-chair of the Patent Trial and Appeal Board Proceedings Practice Group at law firm Foley Hoag.