Below you'll find a list of all posts that have been tagged as “dietary supplements”
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 …
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 …
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 …
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 …
“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 …
