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:...
Jun 28, 2024 | Dietary Supplements, FDA and USDA Regulatory Update, Foods
Earlier this year, the FDA released the draft and final guidance topics that are a priority for the agency’s Foods Program to complete during 2024. Since January, the FDA has issued the following guidances that were on the list: New Dietary Ingredient (NDI)...
Jun 17, 2024 | Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month
Product Claim Substantiation By Jay Ansell, EAS Independent Consultant Substantiating a product claim is required by U.S. law and can help brands avoid regulatory action or provide an effective defense in litigation. For example, in April 2023, the US Federal Trade...
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...
