Insights on Food, Drug, Medical Device & Cosmetic
277 total results. Page 5 of 12.
Partner Emily Leongini and Associate Shoshana Golden were quoted on US Food and Drug Administration’s (FDA) request for additional information from HRA Pharma’s NDA sponsor of a proposal for the country’s first over-the-counter (OTC) daily oral contraceptive.
Food, Drug, Medical Device & Cosmetic Practice Leader Brian Waldman will present at the Healthcare Distribution Alliance’s (HDA) 2022 Traceability Seminar on October 13.
On September 28, 2022, the Food and Drug Association announced a proposed rule to redefine the implied nutrient content claim term “healthy” to more closely reflect current nutrition science and Federal dietary guidelines.
ArentFox Schiff is pleased to announce that 121 attorneys have been recognized by The Best Lawyers in America 2023, with an additional six attorneys highlighted as “Lawyers of the Year” and 40 attorneys listed as “Ones to Watch.”
Partner Jill Steinberg spoke with The American Lawyer about ArentFox Schiff’s new Reproductive Health Task Force and the legal challenges that were created when the US Supreme Court overturned Roe v. Wade.
ArentFox Schiff LLP announced today the launch of its Reproductive Health Task Force to counsel clients on legal issues stemming from the repeal of Roe v. Wade.
“Metaverse” is no longer a mere buzzword. Many industries are discovering and developing applications for the Metaverse, and the pharma and biotech industry is no different.
The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an Alert addressing many of the inquiries we have received.
The 2022 edition of Chambers USA: America’s Leading Lawyers for Business has recognized 66 ArentFox Schiff attorneys as leaders in their field.
Environmentally responsible fashion has become a key marketing signal for many global brands, with advertising claims such as “sustainable,” “responsibly sourced,” “organic,” and “recycled” cropping up throughout the fashion industry. These claims respond to growing demand from consumers.
On March 7, 2022, the US Food and Drug Administration (FDA), operating under its New Animal Drug Authority, took a new, important regulatory step forward in assessing genome editing in animals. Specifically, the Agency announced a “low risk” determination and exercise of enforcement discretion.
As you know, in our recent Alert, we addressed the announcement of the members of the FCC’s Precision Agriculture Connectivity Task Force (“Task Force). Now, the FCC has announced the new members of the four “Working Groups” that will assist the Task Force in carrying out its work.
This week, FDA published a draft guidance on the use of registries to support regulatory decision-making, titled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making or Drug and Biological Products.”
On November 18, 2021, just a few days before the Omicron variant suddenly revealed itself to the world, the preliminary results of two Phase III clinical trials were announced by AstraZeneca, bringing new hope to high-risk populations.
In this podcast, Brian Schneider and Megan Daily discuss frequently asked questions from small businesses and nonprofits about contract management.
On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a report on the amount of each listed drug produced over the preceding year.
As critical product shortages arose during the early days of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued guidance documents outlining temporary policies that allowed non-drug manufacturers to produce alcohol-based hand sanitizers and alcohol for use in such hand sanitizers.
In September 2021, Schiff Hardin LLP advised the new owners in the management buyout of the Beer Shop in downtown Oak Park, Ill.
The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals” (the PhRMA Code or the Code).
Sixty-nine Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2022.
Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that could create confusion for clinicians and result in inappropriate medical
Since no COVID-19 vaccines have been granted regular FDA approval, the United States Department of Justice sought to clarify whether the vaccines’ EUA status prohibits the imposition of such requirements.
In a lawsuit filed on June 29, 2021, in Texas state court, a major national retailer alleges that a Texas law restricting its retail locations from selling liquor to consumers violates the Texas Constitution. The retailer is asking the court for a declaratory judgment that Section 22.16 of the Texa
On February 24, 2021, we first reported on the most significant variants of the novel coronavirus then emerging across the globe and here in the United States.
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the goal of safe importation of prescription drugs.”