Jun 3, 2022 | Client Update, Tobacco
FDA’s Center for Tobacco Products (CTP) has announced the selection of a new CTP director, Brian A. King, Ph.D., M.P.H. Dr. King previously worked at the Centers for Disease Control and Prevention’s Office on Smoking and Health. Dr. King is charged with furthering...
Dec 21, 2021 | Client Update, Tobacco
On Dec. 21, FDA issued draft guidance for industry entitled “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” The draft guidance, when finalized, would provide information and recommendations related to the validation...
Dec 1, 2021 | Client Update, Foods
The U.S. Food and Drug Administration (FDA) has issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by the FDA Food Safety Modernization Act (FSMA). This LAAF program recognizes accreditation bodies that...
Nov 17, 2021 | Client Update, Dietary Supplements
Amazon recently announced flexibility for selling partners to demonstrate of Good Manufacturing Practices (GMPs) for dietary supplements. The new policy requires submission of three demonstrations of quality, two of which are mandatory. The third requirement provides...
Oct 12, 2021 | Client Update, Drugs
New Initiatives by FDA FDA has proposed revisions and updates to OTC-drug sunscreen requirements related to maximum sun protection factor (SPF) values, active ingredients, broad-spectrum requirements, and product labeling, among other provisions. This effort aims to...
Oct 12, 2021 | Client Update, Tobacco
U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products, providing additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial...
