Patient injured because of event described in black box warning: Company still liable, long established FDA approved warnings not sufficient...
Patient injured on generic drug: innovator company could be liable for inadequate warnings...
FDA-approved labeling is no longer a regulatory and liability safe zone. Companies face rapidly escalating FDA, product, reimbursement and patent liabilities tied to labeling management. Penalties, damages and fines are hitting billion-dollar-plus levels, with consideration of direct liability for executives being openly discussed. Traditional labeling development and management approaches that center on FDA approval and adverse event reporting are not up to the task of protecting companies and their executives. This audio conference explains what has happened over the last year and likely changes for the coming years and what to do now to position products for success and avoid liability or regulatory disaster.
Developing a Post-Approval Labeling Risk Management Strategy is being presented by Gary Gamerman, President, of Seraphim Life Sciences Consulting LLC and airs on Tuesday, December 1, 2009. For more details or to register, please visit our site at www.fxconferences.com
