Sep 21, 2021 | Drug and Device Corner, Drugs, Medical Devices
As part of the 2020 CARES Act, section 506J has been added to the FD&C Act. This section requires manufacturers of certain medical devices to report any interruption or permanent discontinuance in manufacturing to the CDRH. The list of relevant devices can be...
Aug 23, 2021 | Drug and Device Corner, Drugs, Medical Devices
FDA has announced most FY2022 user fee rates this month, conspicuously missing are the OMUFA 2022 user fee rates. We will continue to monitor Federal Register notices and share information as soon as it becomes available. Federal Register Vol. 86, No. 142 announcing...
Jul 28, 2021 | Drug and Device Corner, Drugs, Medical Devices
The FDA has planned a public webinar titled Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency. Please follow the link to register for this webinar scheduled for 25 August 2021. Recently published in the Federal Register, FDA has...
Jun 20, 2021 | Drug and Device Corner, Drugs, Medical Devices
The FDA has published the OMUFA Arrears list on their OTC Monograph User Fee Program webpage, with information as of 11 June 2021. In addition to establishments being named on the arrears list, drugs manufactured at facilities that have not satisfied their OMUFA...
May 26, 2021 | Medical Devices, On Demand Webinar
Medical Device Manufacturing – A Look at FDA Enforcement Trends EAS Complimentary Webinar Presented by George Calafactor, Ph.D., EAS Independent Consultant. A look at FY 2020 FDA observations for medical device manufacturers shows a clear focus on procedural integrity...
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...
