NEWS HIGHLIGHTS

A single review of the past year within the biopharmaceutical industry cannot comprehensively cover all developments. In 2017, FDA issued 226 draft and final guidance documents addressing its current thinking with regard to food, laboratory, blood banking, drug, and device regulations. With respect to the research of drugs and biologics, some of these guidances covered topics in drug and biologic technology, product classification (drug, device, or combination), pediatric rare and serious diseases, and software as a medical device (SaMD). In the following segments, a few of these topics are addressed, particularly as they pertain to areas of heightened activity in the industry. Under new FDA leadership, the industry looks forward to further support of innovation in clinical research.

Experts from the Cambridge, MA CRO will gather with industry leaders to discuss the impact of technology on clinical research.

Cambridge, MA-based clinical research organization to manage Phase 1 advanced solid tumors and lymphoma study.

Susan Boquist has joined PROMETRIKA’s Statistical Programming Team as Associate Director.

Heather Paden, MS, has joined PROMETRIKA’s Leadership Team as Head of Clinical Operations.