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Healthy or Not? FDA Explains New Standards in Latest Webinar

On April 10, 2025, the Food and Drug Administration (FDA) released a pre-recorded webinar outlining the updated "healthy" nutrient content claim rule. As we previously discussed, the rule will go into effect on April 28,...more

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

The Major Statement: FDA's Recent Q&A Guidance and Rulemaking on Direct-to-Consumer Prescription Drug Advertisements and the...

On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more

Want to Describe Your Products as Vegan? Here's What You Need to Do

The terms vegetarian and vegan are becoming more common. Initially, how to be a practicing vegetarian or vegan was the focus. Now, these terms are used to describe not only a lifestyle, but foods, cosmetics, and clothing. ...more

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