Jul 25, 2024 | Drug and Device Corner, Drugs, Medical Devices
FDA has sent notices to drug establishment registrants reminding OTC hand sanitizer manufacturers who entered the market solely to provide hand sanitizer during the COVID-19 public health emergency, that beginning FY2025 OMUFA facility user fees will become mandatory....
Jul 1, 2024 | Drug and Device Corner, Drugs, Medical Devices
Final reminder that CARES Act drug amount reports for 2023 are due by 31 July 2024. If you need assistance with this process, reach out to Victoria Pankovich for support. The FDA announced the availability of a final guidance for industry titled “Facility Readiness:...
May 29, 2024 | Drug and Device Corner, Drugs, Medical Devices
Final reminder that OMUFA facility user fees are due 1 June 2024. Per MoCRA, responsible persons are required to submit any serious adverse event reports to the FDA within 15 business days of receiving such report. Cosmetic labels are required to include a domestic...
Apr 25, 2024 | Drug and Device Corner, Drugs, Medical Devices
FDA announced the fiscal year 2024 OTC-Monograph Drug User Fee rates in the Federal Register Vol 89, No. 62 published 29 March 2024. These fees cover FDA’s FY2024 which runs from October 2023 through September 2024. The facility fees for FY 2024 are due on 3 June...
Mar 28, 2024 | Drug and Device Corner, Drugs, Medical Devices
Reminder that CARES volume 2023 reports are due no later than 1 July 2024. Highlighted Guidance Documents Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide FDA is issuing this Technical Conformance Guide to assist registrants of drug...
Feb 26, 2024 | Drug and Device Corner, Drugs, Medical Devices
The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very...