Adverse Event Reports on the Rise – Is there a Safety Issue?

Does FDA’s expectation of increased serious adverse event reports involving dietary supplements signal a safety issue with these products? In recent months, the U.S. Food and Drug Administration (FDA) has been advising dietary supplement companies to review their SOPs regarding adverse event documentation and reporting of serious adverse events to the FDA. FDA believes that there are good indications that …

Webinar: CCPSA to be Offered by SafetyCall

A webinar designed to help manufacturers understand and prepare for the ramifications of the new Canada Consumer Product Safety Act (CCPSA) will be presented at 12:00 p.m. CDT on September 14, 2011, by SafetyCall International, an industry leader in adverse event management and post-market surveillance services for industry. The webinar, “How the Canadian Consumer Product Safety Act WILL Affect Your …