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...
Apr 3, 2024 | Foods, Issue of the Month
Control of Cronobacter in Dairy Dryer and Packaging Rooms By Beth Koenig, EAS Independent Consultant What Is Cronobacter and Why Should We Be Concerned About It? Cronobacter, a genus of bacterial pathogens in the Enterobacteriacea family is of considerable concern in...
Apr 3, 2024 | Drugs, FDA and USDA Regulatory Update
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...
Apr 3, 2024 | Dietary Supplements, FDA and USDA Regulatory Update
Today, the U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s...
Apr 1, 2024 | FDA and USDA Regulatory Update, Foods
On March 20, 2024, the US FDA issued a new import alert for human food products with detectable levels of chemical contaminants that may present a safety concern to human health. The Import Alert 99-48, Detention without Physical Examination of Foods Due to Chemical...
Mar 28, 2024 | FDA and USDA Regulatory Update, Tobacco
Database Lists Tobacco Products—Including E-Cigarettes—That May Be Legally Marketed Today, FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The...
