FDA, CMS Heads Press For 'Single Front Door' For Real-World Evidence
US FDA, CMS and NIH continued push for more collaboration. Co-agency article outlining collaboration on real-world evidence suggests one path forward under a new administration.
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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.
As industry continues to nudge CMS to follow FDA's lead in making reforms that streamline the path to market for innovative new devices, the agencies are themselves floating solutions. All sides are thinking up strategies to rely on FDA's determination that a device meets certain "breakthrough" standards to trigger a streamlined path to data-conditioned reimbursement. But some in industry are concerned about an overemphasis on national, rather than local, coverage, and, in particular, the Medicare coverage-with-evidence-development process.
Moderna is pursuing a single-antigen strategy even though some of its mRNA vaccines have included multiple antigens; the SARS-CoV-2 spike protein likely provides the best antigen for developing immunity against the virus.