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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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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….
Will the FDA Eliminate Self-Affirmed GRAS? What the Proposed Rule Could Mean
The conversation around self-affirmed GRAS is evolving quickly, with lawmakers and regulators signaling potential changes that could reshape how food ingredients are evaluated and brought…
FDA GRAS Reform in 2026: What Food and Ingredient Companies Need to Know
The landscape of food ingredient safety is entering a period of significant transition in 2026. For decades, the “Generally Recognized as Safe” (GRAS) pathway has…
The FDA’s Quality Management System Regulation (QMSR): What the New Inspection Framework Means for Medical Device Companies
The medical device industry is currently navigating one of its most significant regulatory shifts in decades. For nearly thirty years, the Food and Drug Administration…
The FDA’s New Approach to “No Artificial Colors” Claims: Compliance Risks and Legal Considerations
The U.S. Food and Drug Administration has announced a new enforcement approach to products labeled “no artificial colors,” signaling heightened scrutiny for food and beverage…