New FDA guidance on device approval considerations

FDA recently issued new final guidance for medical device manufacturers navigating the premarket approval (PMA) and de novo decision pathways.  The document, entitled Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and...

New models of biotech financing

It’s a brave new world when it comes to financing startup and early stage biotechs, and particularly for pharmaceutical development groups. No longer are there hundreds of pharma-focused VC firms able to independently fuel and sustain the growth of drug development...
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