Posts by Marc Sanchez
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 regulatory law. When I first opened our doors, the regulatory landscape for food, drugs, medical devices, and cosmetics looked vastly different. We were operating before the Food Safety Modernization Act…
Read MoreFDA’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 as No Action Indicated, but FDA can extend a one-day visit on the spot when significant observations surface. The real message is continuous readiness, because you may not control whether…
Read MoreRegistration 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 FDA’s January 2026 draft guidance on its records-access authority signals that the safety substantiation, adverse-event, and supplier records you create today may be reviewed tomorrow. Build product-specific files, a real serious-adverse-event system, and updated supplier contracts now. Many cosmetic companies approached the Modernization of Cosmetics Regulation Act of…
Read MoreThe 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 now in force — not a future deadline. The substance is largely familiar, but terminology, risk emphasis, and a few requirements shifted, and FDA inspections (including one-day assessments) will evaluate…
Read MoreFDA 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. First, FDA initiated two proof-of-concept trials that report endpoints and data signals to the agency in real time: AstraZeneca’s TRAVERSE study in mantle cell lymphoma and Amgen’s STREAM-SCLC study in…
Read MoreAfter FDA’s ENDS Guidance: Why Importers and Retailers Still Face Enforcement Risk
FDA’s Guidance Is an Enforcement Policy, Not an Authorization On May 8, 2026, FDA issued Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization (published in the Federal Register on May 12, 2026). The guidance describes how FDA intends to prioritize enforcement against certain electronic nicotine delivery system (ENDS) and oral nicotine pouch…
Read MoreMoCRA 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 deadline may already be here. Facilities that registered by the initial July 1, 2024 deadline must renew by July 1, 2026 at the latest, and many have renewal dates earlier…
Read MoreFDA Issues New Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products: What Manufacturers, Importers, and Retailers Should Know
FDA’s New Guidance Signals a More Targeted Enforcement Strategy for Vapes and Nicotine Pouches On May 8, 2026, the FDA issued final guidance titled “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” The guidance applies to certain electronic nicotine delivery systems (ENDS) and oral nicotine pouch products that are currently marketed without…
Read MoreFDA 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. That document was officially retired on February 2, 2026, the same day the FDA’s new Quality Management System Regulation took effect. If your inspection readiness plan is built around QSIT,…
Read MoreFlavored E-Cigarette PMTAs in 2026: What FDA’s New Draft Guidance Actually Changes
The FDA’s Center for Tobacco Products issued a new draft guidance on March 9, 2026, that is the most detailed statement yet on how the agency will evaluate premarket applications for flavored e-cigarettes. The guidance formalizes a flavor-specific, evidence-scaled framework — and it shifts FDA’s prior position on device access restrictions in a way that…
Read MoreFDA 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. On January 6, 2026, FDA issued a revised final guidance replacing its 2019 General Wellness policy. The update doesn’t rewrite the rules, but it meaningfully clarifies what companies using non-invasive…
Read MoreWill 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 to market. While the FDA has not eliminated the pathway, proposed reforms and increased scrutiny suggest that companies relying on this framework should begin preparing now. For businesses, the real…
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