Pearl IRB proudly announces the completion of a clean FDA audit. There were no significant findings during the May 2017 audit and FDA issued no 483s. Our AAHRPP accredited IRB operates in compliance with all federal and state regulations governing clinical research....
The NIH-FDA Joint Leadership Council and TransCelerate BioPharma released updated common protocol templates (CPT) last week to accelerate clinical development. An Outsourcing-Pharma.com article and interview with TransCelerate CEO, Dalvir Gill, details some of the key...
Pearl IRB is pleased to announce the hiring of Masheka Fuqua as a Clinical Research Associate (CRA) serving biopharmaceutical, medical device, and diagnostics companies. Fuqua brings over a decade of clinical research experience to Pearl Pathways, including the...
China’s Food and Drug Administration (CFDA) set a goal to push drugs to clinics faster. How will they accomplish this goal? Recent policy proposals suggest CFDA are looking at the US Food and Drug Administration (FDA) for answers. Imitation is the greatest form of...
The Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on May 17, 2017 designed to provide someone new to the medical device industry a background in FDA regulation and to hone the skills of more experienced practitioners. This program has been...
