13 March 2012 -- The Regulatory Affairs Professionals Society (RAPS) will host a webcast tomorrow, 14 March, at 12:00 pm EDT, on how healthcare product companies may handle requests for off-label information while remaining in compliance with US Food and Drug Administration (FDA) requirements.
FDA has recently issued several draft guidances and clarifying statements about how to appropriately handle requests for off-label information, most recently in its December 2011 draft guidance, Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices. This RAPS webcast, Providing Off-Label Information: FDA’s Latest Guidance, will provide an overview of all of FDA's guidances pertaining to this area. Dale Cooke, vice president/group director, Regulatory Review, Digitas Health and Razorfish Health, will explain how they fit together to give a comprehensive picture of how to provide information healthcare providers need while remaining compliant with the legal prohibition on marketing products for unapproved uses.
- Dale Cooke, vice president/group director, regulatory review, Digitas Health and Razorfish Health
- David Ralston, senior director of business conduct, Gilead Sciences
90-minute webcast entitled Providing Off-Label Information: FDA’s Latest Guidance
14 March, 12:00–1:30 pm EDT
How to Access:
Members of the working media may request access to this live RAPS webcast or to the recording by contacting Zachary Brousseau, senior manager, communications, RAPS, at email@example.com or +1 301 770 2920, ext. 245.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org