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 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 7, 2021 | Dietary Supplements, Foods, Issue of the Month
By Gisela Leon, EAS Independent Consultant and Instructor for Food and Dietary Supplement Labeling Seminar In times of COVID-19, many people are restricted to staying at home, working from home, and cooking at home more than ever before. Cooking at home requires the...
Jan 1, 2021 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices
FDA announces FY2021 OMUFA facility user fees in the Federal Register Vol 85, No 249. These fees are effective 1 October 2020 through 30 September 2021. Each facility required to pay the user fee will need to generate a user fee cover sheet via the FDA’s User Fee...
Dec 11, 2020 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Medical Devices, Tobacco, Veterinary
We are proud and excited to announce that Micro Quality Labs (MQL) has joined the Certified Laboratory family of companies. MQL is an ISO accredited, independent analytical testing laboratory, providing state-of-the-art instrumental chemical and microbiological...
