FDA Extends Parallel Review Program ‘Indefinitely’
Executive Summary
The program, which allows select manufacturers to have their products reviewed simultaneously for FDA approval and Medicare coverage, has been in the pilot stage since 2011. Now it is formally in full implementation mode and the agencies are looking for more manufacturers to participate.
You may also be interested in...
FDA, CMS Will Use Parallel Review For Pain-Control Alternatives To Opioids, Medicare Official Says
The Medicare agency is working with US FDA on a parallel review process for non-addictive medical device pain control products and non-opioid drug alternatives to treat chronic pain, Kimberly Brandt, a CMS deputy administrator, told the Senate Finance Committee April 19.
First Expedited NGS Test Breaks Through FDA Review
FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.
UK Health-Tech Assessor Signs On With FDA Payer Task Force
UK NICE has joined the FDA’s Payer Communication Task Force, which helps manufacturers gain detailed feedback from insurers and other stakeholders during product development. It is the first participant from outside the US.