FDA News Update
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.
FDA Regulatory Assessments in Fundraising
Explore how regulatory assessment influences funding for medical devices, ensuring compliance and investor confidence in healthcare innovations.