This past December, the U.S. Food and Drug Administration (FDA) issued a biosimilar industry guidance on a variety of topics. Mostly overlooked was a Q&A regarding safety protections in a 351(k) application. The FDA...more
In December 2016, the FDA published an industry guidance related to the Biologics Price Competition and Innovation Act. This guidance offers suggestions to sponsors on the design and use of clinical pharmacology studies to...more