Perspectives on Life Sciences

The US Food and Drug Administration (FDA) recently issued a draft guidance document announcing that it does not intend to regulate low-risk products intended for general wellness only as medical devices.

The last decade has seen enormous growth in the human tissue products industry, following the Food and Drug Administration’s establishment, in 2001, of a tiered approach to the regulation of these products (referred to as “human cells, tissues and cell- and tissue-based products,” or “HCT/Ps”).

The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.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

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On July 11, 2014, the FDA issued a new Draft Guidance (the Guidance) that will require drug companies to submit information on most drug samples that they distribute in the United States.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).

The US Supreme Court has agreed to consider a dispute between Pom Wonderful (Pom) and The Coca-Cola Company related to whether a drink label can be considered deceptive under federal false advertising laws, but permissible under regulations of the Food & Drug Administration (FDA).

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.”

The US Food and Drug Administration recently published a proposed rule relating to food defense, as part of its implementation of the FDA Food Safety Modernization Act of 2011 (FSMA or the Act).

On December 17, 2013, the US Food and Drug Administration (FDA) published a long-awaited Proposed Rule (PR), which requires manufacturers of antibacterial hand soaps and body washes to submit data and information to the agency.

FDA based its determination on current scientific evidence establishing the health risks associated with the consumption of trans fat.

The US Food and Drug Administration (FDA) has released its much-anticipated final guidance outlining how it intends to oversee developers of mobile medical applications that run on mobile phones and tablets.

Thirty-three Arent Fox attorneys have been ranked at the top of their profession by The Best Lawyers in America.

Arent Fox Intellectual Property partner Marylee Jenkins was quoted in numerous news outlets following her oral argument before the Supreme Court of the United States yesterday in a case over the legality of patenting human genes.