FDA News Update
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 FDA’s January 2026 draft guidance on its records-access authority signals that the safety substantiation, adverse-event, and supplier records…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….
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…