by Marc Kleinman | Apr 11, 2012
FDA recently issued a warning letter to clinical investigator Betty Tuller, PhD, after she purportedly violated several requirements under 21 CFR Part 312 while working at Florida Atlantic University’s Center for Complex Systems and Brain Sciences. According to the...
by Marc Kleinman | Apr 11, 2012
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...
by Marc Kleinman | Apr 11, 2012
Dr. Bruce Booth, Partner at Atlas Ventures, recently published an article on Forbes outlining the various models (or “worldviews”, as he calls them) of startup and early-stage biotechs, and how those models are perceived and evaluated for investments among the Venture...
by Marc Kleinman | Apr 11, 2012
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...
by Marc Kleinman | Apr 11, 2012
In the wake of the recent commotion surrounding flawed research at Duke University on diagnostic tools based on molecular patterns (“omics” tests), an Institute of Medicine (IOM) panel has issued a report entitled Evolution of Translational Omics: Lessons Learned and...
