Sep 9, 2024 | FDA and USDA Regulatory Update, Medical Devices
Please see below information regarding FY2025 Medical Device User Fees which go into effect 1 October 2024. Keep in mind, the FY2025 facility user fee must be paid prior to processing your annual renewal during the renewal period Oct 1 – Dec 31. FY2025 Medical Device...
Sep 4, 2024 | Foods, Issue of the Month
Product Imports Into the U.S That Contain Meat and Poultry: Maneuvering the Process? By Ronnie Dunn, EAS Consulting Group Independent Consultant Importing meat, poultry, and egg products into the U.S. can be a daunting and confusing task. There are numerous...
Sep 4, 2024 | Did You Know, Dietary Supplements, On Demand Webinar
AHPA Claims Substantiation Tools and Trends Presented by Paula Brock, Ph.D., MCSI This is a portion of a webinar produced by the American Herbal Products Association (AHPA) originally held July 9, 2024. Enter Your Information to Watch Now By clicking submit above, you...
Aug 30, 2024 | FDA and USDA Regulatory Update, Foods
WASHINGTON, August 28, 2024 – The U.S. Department of Agriculture (USDA) announced today the availability of an updated guideline that makes recommendations to strengthen the documentation that supports animal-raising or environment-related claims on meat or poultry...
Aug 28, 2024 | Drug and Device Corner, Drugs, Extra Article, Medical Devices
FDA issued a proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for OTC human use, as currently described in OTC Monograph M013. The proposed change will require the addition of a warning to the...
Aug 19, 2024 | FDA and USDA Regulatory Update, Tobacco
Recently, FDA and the Department of the Treasury are announcing a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of Electronic Nicotine Delivery System (ENDS) products into the electronic imports system operated...
