by Waylon Wright | Dec 15, 2017
The United States Food and Drug Administration (FDA) released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases, Outsourcing-Pharma.com reports. FDA collaborated with the European...
by Waylon Wright | Nov 29, 2017
European notified bodies currently face significant stress on their resources and expertise. Completing assessments of the device component of higher-risk drug/device combination products is proving to be a significant challenge for the EU as it enters the...
by Waylon Wright | Nov 28, 2017
Join Diana Caldwell, President and CEO of Pearl Pathways, this Friday, December 1, 2017 at Purdue Foundry as she discusses “The Power of LinkedIn for Life Science Professionals.” Foundry Grounds occurs each Friday and involves conversations, presentations...
by Waylon Wright | Nov 27, 2017
Gretchen Bowker, COO and Co-founder of Pearl Pathways, will discuss the regulatory approval process at the VisionTech Partners meeting on Thursday, November 30, 2017. The event, “Don’t Wine about FDA – Regulatory 101 with Pearl Pathways,” is...
by Waylon Wright | Nov 22, 2017
It should come as no surprise that the volume and diversity of clinical trial data is expected to rapidly increase over the next few years. The proliferation of mobile health tech, real world evidence (RWE), electronic data capture (EDC) systems, etc. in the clinical...