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Food and Drugs Law
United States
Foley Hoag LLP
Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate.
Arnold & Porter
11. COVID-19 and Life Sciences, the US government has used a wide variety of public procurement and funding strategies for needed medical countermeasures during the pandemic.
Stites & Harbison PLLC
In December 2023, the U.S. Supreme Court heard oral arguments in the case of Harrington v. Purdue Pharma, L.P., Case No. 23-124. Purdue Pharma is the drug manufacturer of the prescription opioid...
The U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD).
Foley & Lardner
Antibody Drug Conjugates (ADCs) represent an innovative class of potent anti-cancer compounds. ADCs are widely used in the treatment of hematologic malignancies and solid tumors.
Greenberg Traurig, LLP
On April 1, 2024, the U.S. Food and Drug Administration (FDA) issued a statement reminding stakeholders, especially animal drug manufacturers and veterinarians...
Sheppard Mullin Richter & Hampton
The Federal Trade Commission ("FTC") has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency's...
Braumiller Law Group, PLLC
The intricate interplay between trade and food security has emerged as a vital global issue, one that is closely interwoven with the tapestry of international conflicts and political instability.
Greenberg Traurig, LLP
A new law regulating third-party food delivery went into effect in Florida on April 2, 2024. In an effort to help restaurants curb unauthorized third-party delivery business practices...
Michael Best & Friedrich
This week, USDA confirmed an outbreak of highly pathogenic avian influenza (HPAI) in dairy herds in Texas, Kansas and New Mexico, afflicting primarily older dairy cows causing decreased lactation...
McDonald Hopkins
Cybersecurity threats target every industry, and food and agriculture are not exempt from this threat. This has piqued the interest of the legislature, which has recently taken steps to counter these threats.
In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates...
Holland & Knight
The U.S. Food and Drug Administration (FDA) has increased regulatory activity with regard to per- and polyfluoroalkyl substances (PFAS).
Greenberg Traurig, LLP
AI stands to transform medical product development by creating efficiencies that shrink timelines and costs, and by producing insights. In fact, according to a Berkeley Research Group (BRG)...
Michael Best & Friedrich
Two months ago, I posted about states banning certain food additives and how doing so can fracture the efforts to create uniformity in the United States food safety system.
This decision is an interesting development in the application of safe harbor law to medical devices.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Failure to disclose heavy metal content has become a familiar theme in false advertising class actions. In recent years, the food and beverage industry has faced an onslaught of lawsuits...
Harness IP
FDA databases may contain useful information about the patentability of drugs and validity of drug patents. Also, remember that documents submitted to FDA and NIH...
Foley & Lardner
Non-interventional studies are invaluable for gaining insights into the actual safety and effectiveness of drugs in real-world settings.
Perkins Coie LLP
On March 18, USDA's Food Safety and Inspection Service (FSIS) published its Final Rule on Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims (Final Rule).
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