Jul 1, 2018 | Ask the Expert, Drugs
By Susan Crane This month’s Ask the Expert is answered by EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane. Susan specializes in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge...
Jul 1, 2018 | Cannabis, EAS in Action, Foods
Independent Consultant Celia Schebella discusses tips for designing a cannabis edible in the state of California that meets customer expectations and regulatory requirements in Cannabis Industry Journal. Designing a cannabis food product with GMPs, local regulations,...
Jul 1, 2018 | FDA and USDA Regulatory Update
Before 2016, FDA regulations for nutrition labeling did not define the term “dietary fiber” but in 2016, FDA issued regulation defining dietary fiber as two types of fiber: [1] non-digestible soluble and insoluble carbohydrates and lignin that are intrinsic and intact...
Jul 1, 2018 | Drug and Device Corner, Drugs, Medical Devices
Federal Register Notice Vol 83, No. 108 FDA is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in...
