REGS 603 DRUG, BIOLOGIC, AND DEVICE REGULATION
This online course is designed to orient students of diverse professional backgrounds to several practical elements that underpin drug, biologic, and device regulation in the US and around the world. It provides the core for the curriculum and is a pre-requisite for all other courses. Elements that are explored are the legal framework for drug regulation, including events that have shaped today's framework; ethical issues in drug/biologic/device development and drug/biologic/device use; global regulatory guidance approaches; types of communications with Food and Drug Administration (FDA), including Investigational New Drug (IND) application, New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) requirements, and 510(k) clearance and Premarket Approvals / Biologics Licensing Applications (PMA/BLA) approval requirements; chemistry, manufacturing, and control (CMC) issues; and post-marketing topics.
Offered
201309