Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more
FDA publishes an advance notice of proposed rulemaking for products containing liquid nicotine.
On July 1, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking (ANPRM) to obtain...more
The guidance calls for 2014 reporting by April 1, 2015.
When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act,...more
The proposal, if adopted, will require new recordkeeping by both processing establishments and retail facilities that grind raw beef products....more
The Supreme Court holds that competitors may bring Lanham Act claims challenging food and beverage labels that are regulated by the FDA....more
The final rule prohibits label claims of food products, including dietary supplements, that are “high in,” “rich in,” or an “excellent source of” DHA or EPA and allows some nutrient content claims for ALA.
On April 28,...more
The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require manufacturers to register...more
New market exclusivity opportunities emerge for pharmaceutical companies.
In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more
FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more
Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising.
Recent Federal Trade Commission (FTC) enforcement activities—including a...more
FDA “reminds” manufacturers of the requirements for food and dietary supplement ingredients and finalizes long-awaited liquid dietary supplement guidance.
On January 14, the U.S. Food and Drug Administration (FDA or...more
Proposed requirements dictate a substantial upgrade of the current regulatory standard of care.
On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more
Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority.
On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more
Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety; comments to FDA are due by May 16....more