Over the past several years, the Food and Drug Administration (FDA) has been phasing in requirements for Unique Device Identifiers (UDI) to be displayed on various classes of medical devices. The UDI system identifies medical devices sold in the United States and is...
During the first full week of September, the Food & Drug Administration (FDA) released a draft guidance titled “Statement of Identity and Strength–Content and Format of Labeling for Human Nonprescription Drug Products.” This guidance outlines suggestions for...
The Biden administration has declared monkeypox to be a public health emergency in the United States. This is going to likely result in emergency use authorizations (EUAs) for medical products to diagnose and perhaps even reduce the symptoms related to the spreading...
On March 3, 2022, the U.S. Food & Drug Administration (FDA) issued a guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff,” to help companies prepare for voluntary recalls. Part 7 of Title 21 of the Code of...
Beginning July 24, 2022, consistent with 21 CFR 1.509(a), food importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. As an Importer, what does this mean for you and your operation? Simply...
On Friday, June 24, 2022, the U.S. Food and Drug Administration (FDA) denied an application to continue selling menthol and tobacco-flavored e-cigarette cartridges manufactured by Juul Labs Inc. FDA ordered the removal of these products from the market, citing these...
The Food and Drug Administration (FDA) is getting closer to requiring manufacturers and distributors of dietary supplements to list their products on a public FDA electronic database. On Tuesday, June 14, 2022, the US Senate Committee on Health, Education, Labor, and...
Structure/function claims commonly appear on dietary supplement labeling, both as a marketing tool and as a means of conveying the benefits of the supplement. Structure/function claims are claims that describe the role of a nutrient or dietary ingredient intended to...
On May 23, 2022, the Food and Drug Administration’s (FDA) Center for Drug Evaluation & Research (CDER) issued a public warning letter to Grimann S.A. de C.V. concerning contradictory information between their product labeling and their electronic drug product...
During the 2020 biennial renewal period, the U.S. Food & Drug Administration (FDA) began requiring food facilities to include a unique facility identifier (UFI) on their registration. The required UFI must be a DUNS number obtained through a third-party company,...
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