Nov 1, 2018 | EAS in Action, EASeNews, Foods
Carl Custer wrote about the challenges of Listeria, Salmonella, extraneous materials and worse in an article published in Food Safety Magazine. Carl also shared some of his experiences at problem-solving both while at FSIS and working with clients as a consultant,...
Oct 26, 2018 | EAS in Action, EASeNews, Medical Devices
Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman discussed innovations and the regulatory landscape in an AdvaMed MedTech blog. Bryan shared his thoughts as FDA continues to harmonize and leverage existing regulatory approaches in increasingly...
Oct 1, 2018 | EAS in Action
EAS Independent Consultant Heather Fairman discussed Own Label Distributor audits of contract manufacturers as well as steps for ensuring their compliance in the Natural Products Insider. “Own label distributors performing contract supplier and/or contract...
Oct 1, 2018 | EAS in Action, Foods
Senior Director Tara Lin Couch, Ph.D. shared Own Label Distributor (OLD) responsibilities in a recent article published in Technoscienze – AgroFOOD Industry HI Tech. Regardless of whether an OLD is domestic or international, the FDA is clear that the OLD is...
Oct 1, 2018 | EAS in Action
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...
Oct 1, 2018 | EAS in Action, Tobacco
Dean Cirotta will moderate a panel at the upcoming FDLI Tobacco and Nicotine Products Regulation and Policy Conference concerning “The Latest on Product Standards and Other Potential Regulatory Action”. The conference, which takes place October 25-26, 2018 in...