The current regulation for Europe is the In Vitro Diagnostic Medical Device Regulation - IVDD - 98/79/EC applicable for IVDs to identify patients likely to respond to particular treatment.  However what you will find is there is nothing in there about regulating a CDx IVD product.  Well not exactly a valid statement ... yes you can find how the device ...

I have heard some great feedback from the CER workshop yesterday! Nothing makes an event more successful than knowledgable, dynamic speakers like  @Matthias Fink & @Keith Morel  but also engaged and interested attendees. Many thank yous to @Rochell Aranha & @Georgiann Keyport   for leading the event on behalf of the RAPS Twin Cities Chapter ...

Victor et al., This is something that we can either set an 'informal" exchange and build on upon it and when we get enough traction (attention) then ask RAPS if they would consider setting a more formal venue or we could leverage this idea as a topic for chapter meetings. Also, I am not be attending this year's Convergence meeting. However, ...

I guess it depends on why the formulation was discontinued. It could be an important part of the pharmaceutical development history that could explain differences in PK or safety between the early and later studies. If the change was to got, for example, from powder filled capsules to a compressed tablet and there was no change in dissolution or bioavailability, ...

I'm also still hung up on the question of who it is that could give CDRH permission to fail, or, perhaps more to the point, who it is that CDRH feels the need to get permission from, as well as the question of what that permission would look like.  Or maybe the better question would be, what a lack of that permission would look like. Because I heard ...