The buzz at ASCO is about more (and more expensive) personalized treatments – but the word on everyone’s lips is “diagnostics.”
And the question is whether FDA is going to be part of the problem or of the solution?
As the science of biologics necessitated the agency’s invention of CBER, so too does the promise of "personalized medicine" demand a new FDA bureau to further the development of 21st century diagnostics.
As CDER begat CBER so too must CDRH bring forth a new progeny. Let’s call it the Center for Diagnostics Advancement.
And let’s end the unfortunate ambiguity over the regulatory pathway for diagnostics.
