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.
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Embattled gene therapy companies will take comfort from desire of FDA and EMA help smooth the process of bringing the novel treatments to market.
Former CMS Administrator (and ex FDA Commissioner) Mark McClellan argues that the Aduhelm experience shows why the Medicare agency needs a bump in appropriations.
CMS chief medical officer Lee Fleisher addresses concerns that the Medicare national coverage determination for Alzheimer’s drugs sets a precedent for accelerated approvals. He and the FDA's Janet Woodcock also discuss prospects for closer collaboration on evidence needs pre-approval.