SafetyCall International Launches New Website and Knowledge Center

SafetyCall International, a multidisciplinary healthcare practice that provides adverse event management, regulatory reporting, post-market surveillance, and consulting services, invites manufacturers and regulatory professionals to explore its newly launched website and Knowledge Center. In addition to being redesigned and improved with more information about SafetyCall®, the site offers fresh new content useful to professionals in the industries SafetyCall serves, including ag-chem …

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 …

The Importance of Best Practices

As Rick Kingston, President of Regulatory and Scientific Affairs at SafetyCall International, has said on numerous occasions, it is important for dietary supplement manufacturers to not only ‘meet the letter of the law’ in regards to manufacturing regulations, but to also define and follow best practices for compliance with these regulations. Dr. Kingston was quoted in “The Tan Sheet” article …

Best Practices in Regulatory Reporting: Are You Compliant with cGMPs?

As Dan Fabricant, Director of the FDA’s Dietary Supplements Program, states in recent communications with Industry, he views the level of non-compliance of dietary supplement manufactures with cGMP’s (current good manufacturing practices) as astonishing. Based on audits that have been completed by the FDA’s compliance division they have estimated that nearly 70% of dietary supplement manufacturers are currently not up …

Welcome to the SafetyCall Blog!

Today SafetyCall enters the blogosphere with the launch of our blog site. Staying true to SafetyCall’s mission of communicating clear and trusted health, safety, and medical information 24/7, the content of our blogs will reflect just that, information and opinions from health care practitioners with a specialized yet broad area of knowledge. That knowledge relates to a clear understanding of …