The California Healthcare Institute will be hosting a free online discussion on Tuesday, October 25, 2011 that addresses the FDA’s recently released draft guidance documents:
- Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review (Aug. 15, 2011)
- Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff – Design Considerations for Pivotal Clinical Investigations for Medical Devices (Aug. 15, 2011)
Date: October 25, 2011 * Time: 1:00 PM EDT / 10:00 AM PDT
This program will provide an overview of these recent draft guidances, including the potential impact for medical device manufacturers and clinical trial sponsors. Key topics will include FDA’s most recent thinking on clinical trial design issues and strategies for developing clinical trials that will support product clearance or approval, as well as how to navigate FDA’s current position on benefit-risk determinations. Time will also be provided for a question and answer session, as well as an opportunity to comment on the recent guidance documents.
Click here to register: http://virtual.elsevierbi.com/AC102511Reg-CHI.html