Perspectives on Food, Drug, Medical Device & Cosmetic

Arent Fox LLP is pleased to announce the expansion of its nationally recognized Food, Drug, Medical Device & Cosmetic practice with the addition of Partner Deborah M. Shelton.

On June 6, the US Department of Agriculture (USDA or Agency) released its proposed revision to Part 340, the regulations implementing USDA’s authority over genetically engineered (GE) organisms, including GE plants.

Last week, USDA’s Agricultural Marketing Service convened a webinar to accept public comments on implementing the hemp provisions included in the 2018 farm bill.

Arent Fox hosted the Institute of Food Technologies and American Society for Nutrition’s 8th Annual Food Policy Impact meeting at the DC office on February 11-12th.

While he did not use a hemp pen like the one used by Senate Majority Leader Mitch McConnell (R-KY) to sign the conference report, President Trump signed into law the 2018 farm bill that includes a provision that legalizes hemp. Specifically, the provision would remove hemp from the federal list of c

Arent Fox FDA Associate Emily Leongini will present at CBI’s Bio/Pharma Compliance Congress on Non-promotional Activities.

Partner Karen Carr and Associate Emily Leongini will participate as speakers at the 3rd Annual Dietary Supplement Regulatory Strategy Conference in December 2018.

NEW YORK – Earlier this year, Yeshiva University’s Katz Graduate Business School introduced a new 36-credit Master of Science in Biotechnology Management and Entrepreneurship designed to prepare future business leaders in the life sciences to successfully navigate the launching new medical drugs.

Brian Ronholm, Senior Director of Regulatory Policy, and Emily Leongini, Associate, will present at FoodSafety Tech’s 2018 Food Safety Consortium.

WASHINGTON — Twenty-four Arent Fox LLP practices have been recognized in the 2019 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.

The Department of Health and Human Services (HHS) has issued a proposed rule (PR) which would require any television advertisement for a drug or biological covered by Medicare or Medicaid to include a disclosure of the product’s “current list price” for a “typical” thirty day supply.

President Trump signed into law a bill that expands the Open Payments reporting requirements.

Partner Karen Carr will moderate the panel “Upcoming USDA Bioengineered Food Regulations” at FDLI’s Food Advertising, Labeling, and Litigation Conference on September 26-27 at Covington & Burling LLP in Washington, DC.

Forty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2019.

Earlier this week the Court of Justice of the European Union, the EU’s highest court, issued a decision clarifying whether the EU would regulate products of innovative breeding techniques, like gene editing, under the EU’s Directive 2001/18, the principal EU law governing the regulation of GMOs.

On July 24, 2018, the House of Representatives approved 283-132 a bill (H.R. 184, the Protect Medical Innovation Act of 2017) to repeal the excise tax on the sale of a medical device by the manufacturer, producer, or importer.

The United States Department of Agriculture and the Food and Drug Administration have recently initiated processes to evaluate and propose revisions to their approaches to the regulation of products of agricultural biotechnology.

Late last week, the Food and Drug Administration declared its jurisdiction over animal cell culture technology through a public meeting announcement and a statement by Commissioner Scott Gottlieb.

The National Confectioners Association (NCA) have invited Arent Fox Partner Karen Carr to present a webinar on the bioengineered food disclosure rule proposed by the US Department of Agriculture on May 4, 2018.

Arent Fox Health Care Partner Stephanie Trunk will speak at CBI’s 14th Annual Medical Device Compliance Congress (MDCC).

Arent Fox Intellectual Property Partner Alex Spiegler and FDA Associate Emily Leongini will present at the International Bar Association (IBA) 6th Annual World Life Sciences Conference.

Arent Fox Associate Emily Leongini will speak at the Food and Drug Law Institute (FDLI) Annual Conference hosted May 3-4, 2018 in Washington, DC.

Karen Carr and Emily Leongini to Present at Q1’s Annual Food Labeling Conference. Arent Fox partner Karen Carr and associate Emily Leongini are scheduled to speak at the Q1 Productions’ 5th Annual Food Labeling Conference.

Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.

Recently, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety Modernization Act.