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…safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for…
…No. 077893), Nexgen Pharma Inc. (ANDA No. 077706), Breckenridge Pharmaceutical, Inc. (ANDA No. 077736), and Kremers Urban Pharmaceuticals Inc. (ANDA No. 076652), FDA proposes to deny pending hearing requests and…
…Register notice, FDA revised a 2006 Comp[liance Policy Guide (CPG), Sec. 440.100, “Marketed New Drugs Without Approved NDAs or ANDAs.” According to this revision, any unapproved new drug product that…
By Jennifer D. Newberger – On August 20, 2014, CDRH issued a guidance document, “Unique Device Identifier System: Frequently Asked Questions, Vol. 1.” The purpose, according to the guidance, is to…
…all products making health-related claims, including food, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps. The FTC maintains that the legal fundamentals of its guidance on substantiation…