Jan 24, 2022 | Drug and Device Corner, Drugs, Medical Devices
Reminder: CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 For application holders filing eCTD...
Dec 21, 2021 | Drug and Device Corner, Drugs, Medical Devices
REMINDER CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 Cover Letter Attachments for...
Nov 19, 2021 | Drug and Device Corner, Drugs, Medical Devices
Final reminder that we are entering the last month of the registration renewal period for medical device facilities and drug establishments, as well as drug listing certifications. The FDA has provided an Electronic Drug Registration and Listing Instructions website...
Oct 27, 2021 | Drug and Device Corner, Drugs, Medical Devices
REMINDER that we are in the renewal period for all drug establishment, and medical device facility registrations, as well as the drug listing certification period. The agency announced this month their intention to withdraw the Temporary Guidances for Alcohol-Based...
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...
