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Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.
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FDA’s Mandatory GRAS Notification Proposal: What Food and Ingredient Companies Should Do Now
FDA’s mandatory GRAS notification proposal, announced on August 10, 2026, would significantly change how companies use the Generally Recognized As Safe, or GRAS, pathway for…
Reflecting on XVI Years: How FDA & USDA Regulatory Law Has Evolved (And What Comes Next)
Celebrating Sixteen Years of FDA Law 2010 — 2026 Our firm celebrates 16 years of practice exclusively dedicated to the complexities of FDA and USDA…
FDA’s New Inspection Pilot Is Not Business as Usual
FDA is piloting one-day inspectional assessments — shorter, targeted “safety screening” visits, with facilities selected by artificial intelligence using risk-based criteria. Most early assessments closed…
Registration and Listing Were Only the Beginning
MoCRA is no longer a registration-and-listing project. FDA’s January 2026 draft guidance on its records-access authority signals that the safety substantiation, adverse-event, and supplier records…
The QMSR Is in Effect — This Is Compliance, Not Preparation
FDA’s Quality Management System Regulation (QMSR) took effect February 2, 2026, replacing the old Quality System Regulation and incorporating ISO 13485:2016 by reference. The framework is…
FDA Real-Time Clinical Trials: What AI-Enabled Development Means for Sponsors (Comment by June 29)
FDA Is Moving Toward Real-Time Trial Oversight In April 2026, FDA announced major steps toward implementing real-time clinical trials (RTCT). Two developments anchor the initiative….
MoCRA Cosmetic Facility Registration Renewals: What Brands Need to Know Before July 2026
If your cosmetic manufacturing facility registered with FDA in early 2024 — which is when the mandatory MoCRA registration deadline first hit — your renewal…
FDA QMSR Is Now in Effect: What Medical Device Companies Should Do Next
If you are a medical device company and you are still preparing for FDA inspections using the old Quality System Inspection Technique guide — stop….
FDA General Wellness Guidance 2026: What Wearable and Digital Health Companies Can and Can’t Do Now
If you’re building a wearable, wellness app, smart ring, recovery tracker, or connected health platform, FDA just updated the playbook — and the changes matter….