FDA News Update
Day 8 Shutdown Update: Expanding Impacts, Quiet Delays, and Hidden Ripples Across FDA and USDA
Day 8 Shutdown Update As the government shutdown reaches its eighth day, the immediate disruptions—halted USDA payments, suspended FDA submissions, and trade delays—are now giving…
Day 7 Shutdown Update: Mounting Strain on FDA, USDA, and CBP
Day 7 Shutdown Update As the federal government shutdown enters its second week, what began as a short-term disruption has turned into a sustained operational…
Day 6 Shutdown Update: Escalation in Delays Across FDA & USDA
Day 6 Shutdown Update As the federal shutdown stretches into its sixth day, disruptions are compounding. The longer the lapse continues, the more delay, backlog,…
Day 3 Government Shutdown Update: FDA, USDA, and Imports
As the federal government shutdown enters its third day, the regulatory and trade impacts are deepening. While essential food safety, public health, and customs functions…
Day 2 Shutdown Update: FDA, USDA, and Import Operations
Day 2 Shutdown As the federal government shutdown enters its second day, more clarity has emerged around the scope of disruptions across FDA, USDA, and…
FDA, Imports, and USDA: What Today’s Federal Shutdown Means for You (Oct. 1, 2025)
FDA Shutdown Bottom line up front: FDA will keep working on carryover user-fee–funded activities and life-safety work, but it cannot accept new user-fee submissions during…
How FDA’s New AI System ELSA Is Revolutionizing Regulatory Review
The U.S. Food and Drug Administration (FDA) has entered a new chapter in regulatory science with the introduction of ELSA—its generative AI tool designed to…
FDA’s 2025 Crackdown: How Unannounced Foreign Inspections Reshape Global Compliance
The U.S. Food and Drug Administration (FDA) is stepping up its global oversight in 2025 with a game-changing initiative—unannounced inspections of foreign facilities. Designed to…
Navigating 2025 Tariff Increases: FDA Compliance Strategies for Regulatory Success
As 2025 unfolds, businesses operating in FDA-regulated industries are facing a fresh wave of challenges due to new tariff increases. These changes bring added pressure…
FDA Flags Prohibited Methylene Chloride in Certain Gel Nail Polish Removers: Industry Takeaways
On April 18, 2025, the FDA issued a public notice identifying several gel nail polish removers containing methylene chloride, a chemical banned in cosmetic products…
BREAKING: FDA v. Wages and White Lion Investments, LLC: A Key Supreme Court Opinion on E-Cigarette Regulation
In a recent decision, the U.S. Supreme Court addressed a significant case involving the Food and Drug Administration (FDA) and the regulation of flavored electronic…
The Mid-Link False Data Case and Tips for Selecting a Reliable FDA Testing Lab
Discover the Mid-Link case and how to choose a reliable FDA testing lab for medical device compliance, ensuring accurate data and smooth FDA approval.