May 24, 2021 | Drug and Device Corner, Drugs, Medical Devices
With the Over-The-Counter Monograph User Fee Program (OMUFA) 2021 facility user fee now past due, the FDA would like to remind all drug establishment manufacturers to make payment immediately. Please note the FDA has not issued invoices for this fee. The agency’s only...
Apr 26, 2021 | Drug and Device Corner, Drugs, Medical Devices
After regrouping in January, the FDA has published their finalized FY2021 OTC Monograph User Fees in the Federal Register Vol 86, No. 57. This is the official announcement industry has been expecting from the agency which gives the required amount and due date for OTC...
Mar 22, 2021 | Drug and Device Corner, Drugs, Medical Devices
Client Updates The FDA has finally taken steps to stop companies that use ‘FDA Certificates’ as marketing tools. The FDA has 2 websites with further information, FDA Calls on Certain Firms to Stop Producing and Issuing Misleading “FDA Registration Certificates” and...
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...
Jan 25, 2021 | 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 | 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...
