Posts by Marc Sanchez
How FDA’s New AI System ELSA Is Revolutionizing Regulatory Review
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…
Read MoreFDA’s 2025 Crackdown: How Unannounced Foreign Inspections Reshape Global Compliance
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…
Read MoreNavigating 2025 Tariff Increases: FDA Compliance Strategies for Regulatory Success
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…
Read MoreFDA Flags Prohibited Methylene Chloride in Certain Gel Nail Polish Removers: Industry Takeaways
On April 18, 2025, the FDA issued a public notice identifying several gel nail polish removers containing methylene chloride, a chemical banned in cosmetic products under 21 CFR 700.19. This action underscores the agency’s continued enforcement focus on prohibited substances in cosmetics and signals heightened scrutiny of non-compliant imports. Key Findings FDA testing revealed that…
Read MoreBREAKING: FDA v. Wages and White Lion Investments, LLC: A Key Supreme Court Opinion on E-Cigarette Regulation
In a recent decision, the U.S. Supreme Court addressed a significant case involving the Food and Drug Administration (FDA) and the regulation of flavored electronic nicotine delivery systems (e-cigarettes). This ruling, which examines the FDA’s authority under the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), has wide-ranging implications for how the agency…
Read MoreThe Mid-Link False Data Case and Tips for Selecting a Reliable FDA Testing Lab
Discover the Mid-Link case and how to choose a reliable FDA testing lab for medical device compliance, ensuring accurate data and smooth FDA approval.
Read MoreFDA Regulatory Assessments in Fundraising
Explore how regulatory assessment influences funding for medical devices, ensuring compliance and investor confidence in healthcare innovations.
Read MoreThe Potential Impacts of AI on FDA Regulation
As AI technologies continue to advance, the FDA is adapting its regulatory frameworks to ensure the safety and efficacy of AI-integrated products on the market.
Read MoreUnderstanding the FDA’s Proposed Rule on Food Labeling
The FDA’s proposed Front-of-Package Nutrition Labeling Rule marks a key step in improving transparency for consumers. Learn more about it in this blog!
Read MoreWhy FDA Staff Losses Are a Public Health Concern
The recent wave of staff reductions at the U.S. Food and Drug Administration (FDA) has raised urgent questions about the Agency’s ability to fulfill its critical mission. The FDA is more than just another government entity—it is the backbone of the nation’s public health infrastructure, responsible for ensuring the safety of $2.6 trillion in consumption…
Read MoreThe Ultimate Guide to FDA Registration: Types, Renewals, and Guidelines
Navigating the complexities of FDA registrations is essential for companies. Here, we will showcase the ultimate guide to the types of FDA registration.
Read MoreThe Role and Importance of a US Agent for FDA Registration
Need a US agent for FDA registration? Get expert legal support for FDA compliance, food facility registration, and more. Contact us today for assistance!
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