July 31, 2012

Webinar: Best Practices for Adverse Event Management and Reporting

On August 9, 2012, Rick Kingston, President, Regulatory and Scientific Affairs at SafetyCall International, will be presenting as a part of the SOCAP International Webinar Series. His presentation is titled, “Best Practices for Adverse Event Management and Reporting” and will cover:

  • Potential implications of pending and newly-implemented changes to regulations over adverse event reporting requirements for consumer products.
  • FDA’s new
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July 19, 2012

Manufacturers role in adverse event reporting and postmarket surveillance to be discussed at the Human Performance and Dietary Supplements Summit

Rick Kingston, President, Regulatory and Scientific Affairs and Sr. Clinical Toxicologist at SafetyCall International will speak on the topic of adverse event and post market surveillance related to human performance dietary supplement at the upcoming summit sponsored by the NIH Office of Dietary Supplements, NSCA, and Abbott Laboratories.

Dietary supplements to enhance athletic and general human performance are widely …

July 6, 2012

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 …