by Katie Oakley | Aug 15, 2014
On behalf of the Society for Clinical Research Sites, Pearl Pathways would like to invite you to attend the 2014 Site Solutions Summit, this October 10-12 at the Omni Amelia Island Plantation Resort in Amelia Island, FL. This year’s meeting focuses on...
by Katie Oakley | Aug 14, 2014
Through a recent draft guidance, FDA has proposed a new risk-based regulatory framework for Lab-developed Tests (LDTs), comparable to existing policies for in vitro diagnostic devices (IVDs). Historically, LDTs have been developed at low-risk for the diagnosis of rare...
by Katie Oakley | Aug 13, 2014
Pearl Pathways is proud to sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. These conferences provide an opportunity for various industry professionals to discuss...
by Katie Oakley | Jul 31, 2014
FDA recently issued an unusual warning letter to a dietary supplement company for unapproved marketing claims, with specific reference to the company’s social media use. The letter explains that under federal law, dietary supplements cannot claim to “treat or cure a...
by Katie Oakley | Jul 29, 2014
With the introduction of two draft guidances, FDA has set new performance goals for the regulatory submission process for generic drug manufacturers. Over the course of a three-year period, the agency will begin to implement these goals and eventually reach a point...
