RE: CMS update on TCET... (formerly known as MCIT)29 Jun 2023 16:23
I have not seen this type of authorisation before, but on the pharma side, the FDA can give approval subject to additional testing (or in this case real world experience). I would hope the FDA would be brave enough to go down such a route rather than heaping delay upon delay.
I do fear a complete response letter is coming…..