News

National Law Review6d
District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...
JD Supra10d
FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic ...
National Law Review13d
Court Rejects Challenge to FDA Approval of Ammonia-Reducing Animal Drug
Yesterday the U.S. District Court for the Northern District of California granted summary judgment to FDA and drug ...
Devdiscourse12d
Health Sector Faces New Challenges Amid Trump Administration's Moves
The health sector faces significant challenges due to recent actions from the Trump administration. Key issues include tariffs on Indian pharmaceuticals, FDA staffing changes, legal battles over drug ...
CSNews9d
FDA's Crackdown on Flavored Vapor Products Survives Supreme Court Challenge
A lower court will reconsider whether the agency should have considered an e-cigarette manufacturer's marketing plan.
JD Supra14d
GLP-1 Receptor Agonists: Drug Litigation Overview and Trends
The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation ...
Devdiscourse12d
Tumult in Health Sector: Trump's Decisions Impact FDA, Unraveling Developments from Gene Therapy to Measles
The summary presents key developments affecting the health sector, including disruptions in the FDA due to Trump's layoffs, ...
CNN15d
Supreme Court backs FDA’s denials of flavored vaping products for now
The Supreme Court on Wednesday backed a series of decisions by the US Food and Drug Administration to deny market access for flavored vaping products in a rare win for government regulators that ...