FDA News Update

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.

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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!

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Can Elon Musk Use DOGE to Dismantle the FDA?

As the new Presidential administration takes shape, much of the attention has been on Elon Musk. Using an Executive Order, the President established the Department…

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FDA Greenlights ZYN Nicotine Pouches: A Milestone for Harm Reduction and PMTA Pathway Insights

On January 16, 2025, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 20 ZYN nicotine pouch products through the premarket tobacco product…

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End-of-Year Recap: 2023 Recall Trends and Projections for 2024/2025

As 2024 concludes, it’s time to reflect on the key trends that defined the year in product recalls and consider how 2024 is shaping up….

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US Supreme Court Hears Flavored Vape Case: Key Takeaways for Industry Stakeholders

The U.S. Supreme Court heard oral arguments on Monday in Wages and White Lion Investments. The Court heard arguments regarding the FDA’s defense of refusing…

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Importing FDA Regulated Products for the Holidays in 2024

The holiday season is a peak time for businesses importing goods into the United States. However, when these goods are regulated by the FDA, there…

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Listeria Outbreak Difference Between Deli Meat and Cantaloupes

As has been widely reported, Boar’s Head issued a recall in late July for more than 7.2 million pounds of its ready-to-eat liverwurst and some…

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FDA Tobacco Submission Tracking Number Import Requirement

New FDA and Treasury Rule Proposes Streamlined Import Process for E-Cigarettes In an important step toward regulating the import of Electronic Nicotine Delivery System (ENDS)…

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FDA Plans to Launch Updated Submission Portal for New Tobacco Product Applications in 2025

The FDA’s Center for Tobacco Products (CTP) has announced its plans to unveil the CTP Portal Next Generation (“CTP Portal NG”) in 2025, an improved…

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Supreme Court Agrees to Hear Case Challenging FDA’s Vape Regulation

Supreme Court Grants FDA’s Petition for Certiorari in Wages and White Lion Investments v. Food & Drug Administration In a significant move that could reshape…

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The Impact of the Supreme Court Striking Down Chevron on FDA Regulation

As has been widely reported today, the United States Supreme Court overturned a 40-year old precdent known as the Chevron Doctrine. There are excellent write-ups…

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