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.