FDA News Update
Day 13 Shutdown Update: Litigation Arises Amid Deepening Government Pause
Shutdown Update The federal shutdown has entered its 13th day, and the ripple effects are now extending into unexpected corners of the regulatory and legal…
Day 12 Shutdown Update: Layoffs Accelerate, Agency Strain Intensifies
Shutdown Continues As the government shutdown moves into its twelfth day, scattered but increasingly stark reports of layoffs and staffing reductions are emerging. While few…
Day 10 Shutdown Update: Regulatory Fatigue Deepens as Stakeholders Brace for Delayed Recovery
Regulatory Shutdown Update With the federal government shutdown now in its tenth day, signs of strain are evident across all regulatory fronts. What began as…
Day 9 Shutdown Update: Growing Operational Fatigue and the Long Tail of Delays
Day 9 Shutdown As the federal government shutdown enters its ninth day, agencies and stakeholders are moving from temporary disruption into sustained constraint. While core…
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…