Can Your Adverse Event Reporting Practices Affect Your Insurance Rates?

Rick Kingston recently spoke at the Consumer Healthcare Products Association’s Regulatory and Scientific Conference regarding Best Practices in Safety Surveillance. During his presentation, Rick explained how dietary supplement firms and manufacturers with best practices in place for adverse event reporting are most likely to receive the best insurance rates. Rick was quoted in “The Tan Sheet” Vol. 20, No. 22 …

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 …

Is your Company Compliant? Learn More at our “Best Practices” Webinar

“Best Practices” for post-market surveillance & regulatory reporting of dietary supplement and OTC drug adverse events.

Although “Best Practice” AE Processes can be fairly straightforward, there are a variety of challenges a manufacturer must overcome when implementing an AE system. These can include designing a database, developing SOP’s for managing, documenting, analyzing and reporting indicated events, and overcoming internal …