Trickle Up Economics? The Case For Funding US Medicare Coverage Reviews
Former CMS Administrator (and ex FDA Commissioner) Mark McClellan argues that the Aduhelm experience shows why the Medicare agency needs a bump in appropriations.
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Moving Beyond Aduhelm: Cell/Gene Therapy May Be ‘Poster Child’ For What Comes Next
Former FDA principal deputy commissioner Amy Abernethy says cell and gene therapy is an area primed for improved ‘parallel conversation’ between FDA and CMS on data requirements.
Sustainable Funding for Regulatory Science: FDA, Industry Hope Fourth Time is the Charm
FDA is trying one more time to secure significant resources to fund regulatory science. FDA's leadership is making good progress with key figures in the Administration and on the Hill-but the money still isn't there.
The Power Of The Open Public Hearing
The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.