FDA

FDA Influencer Marketing Guide for Compliance

Navigating the complex landscape of FDA advertising guidelines is crucial for food and drug companies looking to leverage the power of influencer marketing while staying…

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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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Nicotine Pouches and FDA Regulations

Nicotine pouches have gained popularity as an alternative to smoking. Here, we will guide you through the FDA regulations surrounding nicotine pouches.

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Regulatory Attorneys vs Consultants: The Right Choice for You

Understanding the roles of regulatory consultants and attorneys is crucial when bringing a product into the market. Here, we will showcase their differences.

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Confidently Responding to a 510(k) FDA Deficiency Letter

Not sure how to handle an FDA deficiency letter? This guide outlines steps to confidently respond and get your product cleared for market.

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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 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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FDA IHCTOA Letter

What does IHCTOA mean? FDA IHCTOA Letter is an acronym for It Has Come to Our Attention Letter, which is an early alert something may…

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Listing of Ingredients in Tobacco Products

Listing of ingredients in tobacco products will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). The listing…

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Tobacco Health Certificate (NCTTP)

The tobacco health certificate will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). These certificates must be…

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Amazon FDA Registration Proof

Amazon FDA registration proof can be a moving target. Is it a certificate, a screenshot, or something else!? The answer varies from week to week…

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