Pearls of Wisdom
J. Ellen Looney Hired as IRB Administrator
Pearl Pathways is excited to announce the recent hiring of J. Ellen Looney as an IRB administrator. Ellen brings fourteen years of clinical trial experience to Pearl Patwhays and her hiring has Pearl Pathways CEO, Diana Caldwell, very pleased, "Our staff and clients...
FDA Not Meeting Medical Device Performance Goals?
According to a Government Accountability Office (GAO) report, FDA was inconsistent in its review of pre-market approval applications. These findings were based on the years starting in 2003 and ending in 2010. The report also said FDA was “especially” inconsistent...
FDA issues warning letter to clinical investigator studying marketed drugs
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...
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...
Forbes article explores biotech models from the VC perspective
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...