May 30, 2023 | Drug and Device Corner, Drugs, Medical Devices
As we approach June, keep in mind that drug establishment registrations and NDC listings that have had any changes to their information must update their files with the FDA within 30 days. Failing that, the agency expects updates to be submitted the JUNE or December...
May 4, 2023 | Issue of the Month, Tobacco
By Shelly Blackwell, Senior Director for Dietary Supplement and Tobacco Services Over 12 years after the FDA began regulating tobacco products, the long-anticipated Tobacco Product Manufacturing Practices (TPMP’s) have been proposed. The new requirements were proposed...
Apr 28, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that the FDA has announced the 2023 OMUFA user fee rates, please see the Over-The-Counter Monograph Drug User Fee Program (OMUFA) website for full details. Monograph Drug Facility (MDF) Facility fee: $26,153; Contract manufacturing Organization (CMO) Facility...
Apr 5, 2023 | Dietary Supplements, Issue of the Month
By Paula Brock, Ph.D., MSCI, EAS Independent Consultant It is required in the United States that manufacturers and other advertisers of dietary supplements such as distributors, retailers, and endorsers, have adequate substantiation that the claims made about their...
Mar 29, 2023 | Dietary Supplements, FDA and USDA Regulatory Update, Foods
FDA’s latest draft guidance document on Dietary Guidance Statements in Food Labeling shares FDA’s current thinking on label, labeling and marketing statements that aims to help Americans make informed food choices. FDA has long actively supported consumer awareness of...
Mar 29, 2023 | Cosmetics, FDA and USDA Regulatory Update
Contrary to the expectation in the cosmetic regulatory space, the FDA has stopped accepting submissions to the voluntary cosmetic registration and listing program and will not be transferring this data to the program the Agency is establishing for the mandatory...
