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 22, 2021 | Dietary Supplements, 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 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...
Jan 27, 2021 | Medical Devices, Webinar
Medical Device or a Wellness Device? Understanding FDA’s Criteria and Compliance Requirement EAS Complimentary Webinar Presented by Jay Mansour, EAS Independent Consultant April 2, 2021 at 1pm eastern Register Wellness devices are big business, creating an...
Jan 25, 2021 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices
EAS Client Updates Breaking News: FDA Places All Alcohol-Based Hand Sanitizers from Mexico on Import Alert As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency...
Jan 11, 2021 | Medical Devices, Webinar
Medical Device Manufacturing – A Look at FDA Enforcement Trends EAS Complimentary Webinar Presented by George Calafactor, Ph.D., EAS Independent Consultant May 26, 2021, 1:00pm eastern Register A look at FY 2020 FDA observations for medical device manufacturers shows...
