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.
On July 11, 2014, the FDA issued a new Draft Guidance (the Guidance) that will require drug companies to submit information on most drug samples that they distribute in the United States.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On January 13, 2014, the FDA issued a Draft Guidance entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and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.
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.
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.
Deborah Shelton, a Partner in the Food, Drug, Medical Device, and Cosmetic group, will speak in the opening session of ACI’s FDA Boot Camp in September.
Life Sciences Partner Deborah Shelton will be a featured speaker at FDLI’s Introduction to Drug, Biologics, and Biosimilars Law and Regulation course in Boston on July 23-24.
Arent Fox Patent Partner Janine Carlan is a featured speaker at the upcoming American Conference Institute’s Women Leaders in Life Sciences Law Conference.
Arent Fox and Kaiser Associates are pleased to invite you to a reception to kick off the JP Morgan Healthcare Conference. Guests will be able to enjoy networking over craft beer and wine, cocktails, and appetizers. We look forward to seeing you there!