Aug 1, 2024 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month, Medical Devices, Tobacco, Veterinary
How to Build an Achieving Team By Eiman Raouf, EAS Senior Regulatory Consultant Upon entering various organizations, scenarios often unfold where operational efficiency falls short. Quality lapses in production, a surge in customer grievances, or perpetual crisis...
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...
May 2, 2024 | Issue of the Month, Medical Devices
Quality Management System (QMS) Documentation By Jeff VanderHoek, EAS Independent Consultant The design and manufacturing of medical devices requires a high level of quality and reliability to ensure patient safety and regulatory compliance. The Quality Management...
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...
