Jun 1, 2019 | Did You Know, EASeNews
EAS offers holistic and cohesive services for clients looking to submit GRAS and NDI submissions to FDA. From the assessments to design of early feasibility studies, ongoing study oversight with the Contract Research Organization, strategy meetings with FDA and the...
Jun 1, 2019 | Drugs, EASeNews, Issue of the Month
By Miguel Montalvo Though published well over 25 years ago, FDA’s guidance surrounding cleaning validation continues to cause industry confusion. While everyone agrees that cleaning validation is critical, the application of incorrect or ineffective approaches whether...
Jun 1, 2019 | Ask the Expert, Drugs, EASeNews
By Robert Fish Each month EAS independent consultants answer one question sent in by readers of EASeNews. This month’s question on adverse events reporting for both OTCs and dietary supplements is answered by Independent Advisor for Quality and Compliance, Robert...
Jun 1, 2019 | EASeNews, FDA and USDA Regulatory Update, Foods
FDA’s Final Guidance for preparation of Food Contact Notifications for substances that come into contact with infant formula and human milk is intended to help industry understand FDA’s process for evaluating the safety of food contact substances. It incorporates...
Jun 1, 2019 | EAS in Action, EASeNews, Foods
EAS Independent Advisor for Food Law and Regulation, Steve Armstrong, is an invited speaker for the fourth annual CLE Introduction to Food Law conference taking place June 6-7, 2019 at the UCLA Resnick Center for Food Law and Policy. Steve is a third time speaker...