FDA Removes Key Barrier to Real-World Evidence for Drugs and Medical Devices
The U.S. Food and Drug Administration has announced a change to how it evaluates real world evidence in regulatory reviews. In
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December 17, 2025
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[blog_list]
FDA Proposal Signals Major Changes for Sunscreen Active Ingredients
Recent regulatory activity in the United States is drawing renewed attention to sunscreen compliance. In a new announcement, the FDA
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December 17, 2025
FDA Strengthens Infant Formula Recall Oversight After Botulism Case
The U.S. Food and Drug Administration has announced new actions aimed at improving recall effectiveness following an investigation into an
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December 17, 2025
U.S. Congress Introduces Bill Requiring Warning Labels And Ad Limits For “Junk Food”
Members of the U.S. House of Representatives have introduced the Childhood Diabetes Reduction Act of 2025, a bill that would
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December 17, 2025
What the New FDA PreCheck Program Means for Drug Manufacturers
Introduction Announced on August 7, 2025, the FDA PreCheck program is a new initiative aimed at strengthening the domestic pharmaceutical
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August 13, 2025
FDA Proposes Compliance Extension And Releases New Tools For Food Traceability
The FDA food traceability rule is once again in the spotlight. On August 6, 2025, the U.S. Food and Drug
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August 7, 2025
FDA Chemical Screening: What The New EDT Tool Means For Food Safety
The FDA has released a new tool called the Expanded Decision Tree (EDT), which is designed to support chemical safety
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July 31, 2025
FDA approves gardenia blue as Red No. 3 faces phase-out
The U.S. Food and Drug Administration (FDA) has approved gardenia blue, a plant-derived color additive, for limited use in certain
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July 18, 2025
How the SAFE Sunscreen Act Could Change FDA Compliance
Sunscreen compliance in the U.S. may be on the edge of its most significant update in over two decades. On
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July 18, 2025
FDA Updates Food Labeling Compliance Program
The FDA Food Labeling Compliance Program has just been updated to help food manufacturers and importers meet U.S. labeling requirements
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June 26, 2025
FDA Front-of-Package Labeling Deadline Extended
FDA Front-Of-Package Labeling Comment Period Extended The U.S. Food and Drug Administration has extended the comment period for its proposed
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May 11, 2025
Why The FDA Is Phasing Out Petroleum-based Synthetic Dyes
The FDA’s decision to phase out petroleum-based synthetic dyes is poised to bring major change to food manufacturers across the
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April 27, 2025
FDA announces ESG NextGen launch for industry submissions
FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, you’ll now
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April 17, 2025
FDA Releases Cosmetic Facility & Product Registration Summary
On March 13, 2025, the U.S. Food and Drug Administration (FDA) released its first public summary data on the mandatory
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March 26, 2025
Self-Affirmed GRAS May End – What It Means for You
The self-affirmed GRAS pathway may soon be eliminated. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the
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March 12, 2025
FDA Updates Guidance on Genome-Edited Foods
The U.S. Food and Drug Administration (FDA) has published an update to its guidance for voluntary premarket engagement regarding foods
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December 16, 2024
Choosing Between GRAS Notice and Self-Affirmed GRAS
If you’re introducing a new ingredient or additive into food products, understanding the GRAS Notice vs. Self-Affirmed GRAS pathways is
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October 31, 2023
5 Reasons Why Food Labelling Is Important for Your Business
Have you ever looked at a food label and wondered why all that information is there? Labels do more than
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June 7, 2022