Insights on Food, Drug, Medical Device & Cosmetic

The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.

The Food and Drug Administration (FDA) has issued a dozen Warning Letters to dairy farms across the country.

The Food and Drug Administration (FDA) recently issued Guidance that describes circumstances that could occur during a drug facility inspection that might be deemed to constitute a “delay,” “denial,” “limitation,” or “refusal” of an inspection.

The US Food and Drug Administration (FDA) issued final regulations requiring that calorie information be listed on menus and menu boards in chain restaurants, and retail food establishments, and final regulations governing mandatory calorie declaration on food sold in vending machines.

The General Accounting Office (GAO) recently released a report critical of the Food and Drug Administration’s (FDA) and the United States Department of Agriculture’s (USDA) pesticide residue monitoring programs for food.

On September 30, 2014, the US Court of Appeals for the Ninth Circuit unanimously held that the first-in-the-nation Safe Drug Disposal Ordinance passed by Alameda County, California is constitutional.

On July 11, 2014, the FDA issued a new Draft Guidance (the Guidance) that will require drug companies to submit information on most drug samples that they distribute in the United States. The new Guidance is entitled “Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act.”

In an 8-0 decision, the US Supreme Court ruled last week that a private party may bring a Lanham Act claim challenging a food label regulated by the Federal Food Drug and Cosmetic Act (FDCA).

On January 13, 2014, the FDA issued a Draft Guidance entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”