Posts by Marc Sanchez

With the federal government shutdown now in its tenth day, signs of strain are evident across all regulatory fronts. What began as a temporary freeze has now evolved into a systemwide slowdown that will require weeks—if not months—to unwind. Both FDA and USDA are entering a stage of regulatory fatigue, where limited staffing, suspended timelines,…

As the federal government shutdown enters its ninth day, agencies and stakeholders are moving from temporary disruption into sustained constraint. While core public health and safety functions remain active, mounting backlogs, suspended regulatory processes, and deepening data gaps are now defining features of the second week. Industry and agency personnel alike are beginning to focus…

As the government shutdown reaches its eighth day, the immediate disruptions—halted USDA payments, suspended FDA submissions, and trade delays—are now giving way to a broader and more subtle pattern of regulatory slowdown. Beyond the obvious, the shutdown is beginning to affect timelines for rulemaking, enforcement actions, and advisory processes that shape long-term regulatory policy. FDA:…

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 slowdown across multiple agencies. With Congress still at an impasse, businesses regulated by FDA, USDA, and import authorities are now facing tangible, cascading effects—from delayed payments and data blackouts to…

As the federal shutdown stretches into its sixth day, disruptions are compounding. The longer the lapse continues, the more delay, backlog, and uncertainty we see across FDA, USDA, and import/trade operations. Below is our updated picture—and what your team should be monitoring closely. FDA & Regulatory Operations USDA: Program Suspensions Deepen, Field Capacity Erodes 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 continue, clients should be aware of additional service suspensions and operational slowdowns now taking effect across FDA, USDA, and U.S. import operations. FDA: Retained Functions, Shrinking Scope USDA: Payments, Data,…

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 import operations. While essential public health and safety functions continue, significant slowdowns and funding freezes are taking hold. FDA USDA Imports & Trade Key Takeaways We will continue to monitor…

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 the shutdown. Import screening at the border continues, though expect delays. Many USDA APHIS Veterinary Services (VS) functions tied to user fees (including animal import/export services) continue; other routine activities…

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 enhance how the agency reviews, interprets and processes regulatory information. As technology continues to reshape industries, even the most traditional and highly scrutinized government bodies are beginning to adopt AI…

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 tighten compliance and protect the U.S. market from substandard imports, these surprise audits are set to disrupt the operations of overseas manufacturers supplying pharmaceuticals, medical devices, and food products.  If…

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 to pharmaceutical and medical device manufacturers, with potential implications on cost, supply chain efficiency, and regulatory compliance. Companies must now align their FDA compliance efforts with customs and trade requirements…