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 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...
Jan 1, 2021 | Drugs, EAS in the News Drugs, EAS in the News Medical Device, Extra Article, Medical Devices
EAS published an article in MedTech Intelligence on the importance of component GMP requirements for drug-device combination products. “The rapid development of combination products—biologics, pharmaceuticals and their devices—provides great opportunity for...
Jan 1, 2021 | Drugs, Foods, Issue of the Month
Robert Fish, Independent Advisor, Quality and Compliance Every year FDA monitors thousands of recalls of regulated products (over 7,000/year). Though most product recalls are voluntary, the FDA can also order them. Recalls can be very damaging to the reputation of a...
