backRecent developments and abrupt shifts in FDA expectations regarding clinical investigations of drugs and medical devices pose major new challenges for manufacturers. This program will address the opportunities and hurdles of new FDA initiatives for the development of novel drugs and biologics, including the “plausible mechanism” framework, the one pivotal trial “default standard” and guardrails for use of the Accelerated Approval Program pathway. We will explore major shifts in FDA expectations regarding the regulatory authorization of medical devices, including the use of real-world data and real-world evidence to support FDA decision-making. Pertinent to both drugs and devices, we will discuss practical strategies for navigating unexpected and common FDA hurdles on the path of premarket product development and marketing authorization. In addition, we will address new developments in FDA and DOJ scrutiny and criminal enforcement targeted at clinical investigations, including heightened attention to clinical trial fraud, and provide practical tips on how to identify and address clinical investigator, clinical research organization, and clinical site bad actors.
RSVP by May 19. For questions, contact Ella Peek.