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Exponent
Last November, in a potential landmark plastics pollution case, New York Attorney General Letitia James filed a public nuisance lawsuit against a large food and beverage company claiming...
Exponent
Following a voluntary 2020 FDA initiative, grease-proofing agents containing certain per- and polyfluoroalkyl substances are no longer on the market in the U.S.
MoginRubin
The Second Circuit U.S. Court of Appeals has reinstated an antitrust complaint brought by pharma firm, Regeneron Pharmaceuticals, Inc., against the Swiss pharmaceutical...
Steptoe LLP
The US Food and Drug Administration (FDA) published a Final Rule on March 22, 2024, amending its regulation at 21 C.F.R. § 170.105 to provide additional bases upon which the agency may determine that a Food Contact Notification (FCN) is no longer effective.
Exponent
Food and Drug Administration draft guidance for metallic and calcium phosphate coatings on orthopedic devices is now open for comments...
Bass, Berry & Sims
On March 12, the U.S. Court of Appeals for the Second Circuit issued an important decision that sheds light on the test for determining scienter under the federal Anti-Kickback Statute (AKS).
Jones Day
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with several notable changes.
Goodwin Procter LLP
Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.
Holland & Knight
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector.
Michael Best & Friedrich
I've posted a lot about ultra-processed foods (UPF) because there is a plethora of articles in the popular literature about the ostensible health risks of UPF consumption.
Sheppard Mullin Richter & Hampton
Earlier this month, the U.S. Food and Drug Administration ("FDA") issued a draft guidance, "Key Information and Facilitating Understanding in Informed Consent"...
Exponent
Food and Drug Administration's proposal will classify pre-amendment wound dressings and wound washes as Class II or III devices...
Littler Mendelson
In a significant decision about workplace drug use, the Connecticut Appellate Court backed an employer's right to terminate a worker...
Venable LLP
On March 11, 2024, the White House released President Biden's FY 2025 Department of Health and Human Services (HHS) Budget in Brief, which outlines $130.7 billion in discretionary...
Groom Law Group
On March 11, 2024, President Biden released his budget for Fiscal Year 2025. Hewing closely to proposals in its last budget, the Administration's new budget...
Exponent
New guidance provides recommendations to ensure digital health technologies are fit-for-purpose for collecting high-quality clinical data to evaluate medical products.
Exponent
New draft guidance describes factors for determining when evidence generated from real-world data may be used to support FDA decisions on medical devices .
Goodmans LLP
Nitrousink Ltd., the newly formed subsidiary of agri-tech company Save Foods, Inc., recently announced that it has filed an application with the U.S. Patent and Trademark...
Michael Best & Friedrich
New research in the journal Frontiers suggests that broken down plastics can be carriers of a range of endocrine disrupting chemicals (EDC) that can harm human health.
Foley Hoag LLP
In the USA, prescription drug advertising is primarily regulated by the US Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act...
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