Oct 19, 2023 | Cosmetics, FDA and USDA Regulatory Update
As the cosmetic facility registration and product listing requirement date approaches (29 December 2023), companies needing to register their facility, or list cosmetic products should be gathering the information required to submit to FDA. For facilities that need to...
Oct 2, 2023 | Foods, Issue of the Month
A Decade of Vigilance: FDA’s Battle Against Imported Foodborne Illness By Don Abbott, EAS Independent Consultant Introduction Over the past decade, the Food and Drug Administration (FDA), particularly its Center for Food Safety and Applied Nutrition (CFSAN), has been...
Sep 28, 2023 | FDA and USDA Regulatory Update, Foods
On September 28, 2023, the U.S. Food and Drug Administration (FDA) has updated its Food Traceability Frequently Asked Questions (FAQ) to provide additional information about this rule. The Food Traceability Final Rule was published in November 2022 and requires the...
Sep 27, 2023 | FDA and USDA Regulatory Update, Uncategorized
On September 26, 2023, US FDA issued an updated Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. This new guidance material includes a new chapter specific to allergens. Key take-aways include: Establish and Implement a...
Sep 25, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that FY2024 GDUFA payments are due 2 October 2023. The FDA does allow a 20 calendar day grace period, after which arrears lists will be published with the names of companies that have failed to make payment. Failure to pay required user fees by this deadline...
Sep 19, 2023 | FDA and USDA Regulatory Update
On Friday 15 September 2023, the FDA issued a draft guidance shedding light on the much-anticipated MoCRA registration and listing requirements. The guidance, titled “Registration and Listing of Cosmetic Product Facilities and Products” gives an overview of the...
