News

Trump Seeks Ideas to Reduce Prescription Drug Costs
The executive order asks for recommendations to promote “a more competitive, efficient, transparent, and resilient ...
JD Supra7d
Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act
as “devices” under the Food, Drug, and Cosmetic Act (FDCA). The court’s reasoning relied on the 2024 Supreme Court decision that overturned Chevron deference Loper Bright Enterprises v.
F.D.A. Layoffs Could Raise Drug Costs and Erode Food Safety
Trump cutbacks were supposedly aimed at administrators. But scientists in food and drug-testing labs and policy experts who ...
JD Supra11d
Federal Court Strikes Down LDT Final Rule
On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule ...
CNN5d
FDA says it will phase out animal testing requirement for monoclonal antibodies and drugs
The bill amended the Federal Food, Drug, and Cosmetic Act to remove a requirement that sponsors of new drugs use animal studies to get licensure from the agency, allowing them to use animal ...
FDA planning for fewer food and drug inspections due to layoffs, officials say
Around 170 staff were cut from the FDA's Office of Inspections and Investigations this week as part of wider cuts at U.S.
The New York Times7d
The Return of the Great American Stomachache
Since then, America has strengthened those early and basic protections, gradually modernizing the F.D.A. with passage of the 1938 Federal Food, Drugs and Cosmetic Act and other updates ...