CMS drops mandate for controls in registry studies in final LAA decision memo
The CMS has rendered a final coverage decision for left atrial appendage devices, a move driven largely by the successful Watchman PMA by Boston Scientific, which slogged through three FDA advisory committee hearings on its way to the CMS coverage analysis. The final decision memo included several important changes compared to the draft, including that the agency has dropped the demand for a contemporaneous set of patients on medical therapy, making the resulting study a simpler and less expensive one-arm registry study.
POTUS, cancer and shooting for the moon
It was interesting to hear the President become archly ambitious about the oncological equivalent of a moonshot during his most recent State of the Union address. The President said veep Joe Biden would take the lead on an effort to break down "silos of data," which Biden said recently would halve the time needed to make advances in cancer care, and those in the private sector might be wondering how much of this talk of silos has to do with NIH's draft clinical trial data disclosure rule.
Inside the Beltway: User fee negotiations include a look at draft guidance issue
The negotiations for the next user fee schedule are well underway, and the FDA and device makers are addressing what some in industry see as sore spots. The FDA's proposals include development of a "myDevice" portal to allow for a more streamlined and interactive premarket review process, but the FDA has also said it would address the persistent draft status of guidances, vowing to take measures to ensure that guidances "are finalized in a timely manner."