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...
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...
Dec 1, 2020 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices
Revisions to section 801(e)(4)(E)(iii) of the FD&C Act as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act direct FDA to provide certification for Devices Not Exported from the U.S. Manufacturers of devices not exported from the United...
Nov 1, 2020 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices
Recently Published Guidance Documents CDER Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment This guidance is intended to assist sponsors in developing drugs for medication-assisted treatment of opioid use disorder. This guidance...
Oct 1, 2020 | Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices
EAS would like to remind all eNews readers of the importance of an appointed U.S. Agent. The FDA recently deactivated the FDA registrations of 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations. As we head into the FDA...
