Norma Skolnik discussed Adverse Events Reporting (AER) requirements for the dietary supplement industry in Natural Products Insider. The requirements as well as the Guidance for Industry: Questions & Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as required by the Dietary Supplement & Nonprescription Drug Consumer Protection Act,” published in 2007 cover SAE reporting for manufacturers and OLDs as well as FDA notification to companies when FDA receives an SAE involving one of their products.
Posted in EAS in Action.