Feb 25, 2021 | EASeNews, Issue of the Month, Medical Devices
By Elvira Cawthon, EAS Independent Consultant Premarket submissions for medical devices are costly, time-consuming, and denial of a submission can be devastating. Though the FDA Q-Submission (Q-Sub) Program, designed to minimize risk by enabling Sponsors and...
Feb 25, 2021 | Did You Know, Foods
A medical food per FDA is a specific category “formulated to be consumed… under the supervision of a physician and which is intended for the specific dietary management of a disease or condition” which need “distinctive nutritional requirements.” This means that...
Feb 22, 2021 | Drug and Device Corner, Drugs, Medical Devices
CDER’s Work to Meet User Fee Goals During the Pandemic website includes an overview of the agency’s thinking regarding manufacturing facility inspections during the age of COVID-19. As always, the FDA will use a risk-based approach to identify facilities that...
Feb 22, 2021 | Cannabis, EAS in Action
EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D. was interviewed for the National Cannabis Business Industry’s podcast on the future of cannabis consumerism. Listen now on Apple podcast and Stitcher and hear more about the...
Feb 18, 2021 | Did You Know, Dietary Supplements, Drugs, Foods, Medical Devices, Veterinary
In addition to Good Manufacturing Practices, supply chain oversight, labeling, registrations, listings, adverse event tracking and all the other regulatory requirements required by FDA, use of electronic records and submissions adds an additional compliance...
Feb 1, 2021 | Did You Know, Foods
Derived from natural materials, biopesticides, are inherently less toxic than conventional pesticides and when used as a component of Integrated Pest Management (IPM) programs, can greatly reduce conventional pesticide use and improve crop yields. EPA has regulatory...
