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.
You may also be interested in...
The former principal deputy commissioner outlined what she sees as the future data requirements for real world evidence and why cell and gene therapy will lead the way.
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.