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Focus on Regulation

Tag Archives: Food Drug and Cosmetic Act

FDA proposes new ways for prescription drugs to become available over-the-counter

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a prescription, drugs that are currently available only by prescription.  The draft guidance would facilitate these prescription (Rx) to Over-The-Counter (OTC) switches by allowing

FDA Issues New Draft Guidance on Identification of Suspect Products and Notification

On June 11, 2014, the FDA announced the availability of a draft guidance entitled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The draft guidance clarifies for trading partners certain new requirements in the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Supply Chain Security Act (DSCSA). The

A New Landscape of DOJ Sanctions for Pharmaceutical and Medical Device Manufacturers

The U.S. Department of Justice (DOJ) announced another significant settlement with a pharmaceutical company earlier this week.  The settlement with GlaxoSmithKline PLC (GSK) includes:  a criminal plea, through an Information charging the company with two counts of misdemeanor misbranding as well as a single count for failure to report information about the initiation or status

Ninth Circuit Suggests Flexibility in Type Size for Food Statements of Identity

While the Ninth Circuit’s recent ruling in POM Wonderful v. Coca-Cola has received attention for its holding on preemption, the decision provides interesting statements in the technical realm of the FDA’s type-size requirements for statements of identity in food labeling. The issue involved the statement of identity for Coca-Cola’s Pomegranate Blueberry Minute Maid drink, “Pomegranate