The FDA and ASCO have collaborated to create an educational webinar to explain expanded access programs and to clarify the process to access investigational drugs outside a clinical trial. Although it is primarily intended for physicians, the webinar provides valuable information to anyone interested in learning more about expanded access programs.
The program consists of three interactive modules, all with links to key references and resources relevant to the slide content:
1. Introduction to Expanded Access Programs: Presents an explanation of all expanded access programs available
2. Expanded Access Process: Provides information about the process from the perspective of the physician, the FDA, the industry, and the institutional review board
3. Investigator-Sponsor Responsibilities: Furnishes key information regarding the legal responsibilities of physicians as investigators-sponsors
For more information, visit http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/
AccesstoInvestigationalDrugs/ucm217583.htm.
