FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all healthcare professionals, pharmacy students, nurse practitioner students, physician assistants, and medical students. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!
On July 12, 2016, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: An Overview of FDA’s Expanded Access Process and the New Individual Patient Expanded Access Application. The panel presenters were Richard Klein, Director of the FDA’s Patient Liaison Program in the Office of Health and Constituent Affairs (OHCA), Peter Lurie MD, MPH, Associate Commissioner for Public Health Strategy and Analysis, Office of the Commissioner and Colleen Locicero, RPh, Associate Director for Regulatory Affairs in the Office of Drug Evaluation I in FDA’s Center for Drug Evaluation and Research (CDER). The presenters discussed and summarized the purpose of FDA’s expanded access program, including the types of expanded access requests accepted by FDA. They also described the requirements for requesting individual expanded access and the costs physicians may charge patients for single patient expanded access. Finally, they reviewed and explained how to submit single patient IND expanded access requests to the FDA using the new FDA Form 3926.