Recently, Harvard researchers conducted a study involving dietary supplements, later published in the Journal of Adolescent Health, to review adverse event reports from January 2004 to April 2015 using data from the FDA Adverse Event Reporting System (FAERS). The FAERS is a database that contains line listings of select fields of data from Adverse Event (AE) reports contained …
Listen in as SafetyCall’s Rick Kingston Speaks at FDA Public Hearing
The FDA is seeking public comment regarding the availability of scientific data and information regarding Cannabis or Cannabis derived ingredients. This has been a difficult topic for FDA considering the fact that such products are still classified as Schedule I substances at a Federal level. FDA is looking for scientific information to help them determine if there is a path …
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 …