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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…
FDA’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…
Navigating 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…
FDA 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…
BREAKING: 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…
The 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.
FDA Regulatory Assessments in Fundraising
Explore how regulatory assessment influences funding for medical devices, ensuring compliance and investor confidence in healthcare innovations.
The 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.
Understanding 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!
Why 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…
The 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.
The 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!