FDA Removes Key Barrier to Real-World Evidence for Drugs and Medical Devices
Drug and medical device applications may now rely on more real world evidence after FDA removes a major submission barrier.
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December 17, 2025
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[blog_list]
FDA Proposal Signals Major Changes for Sunscreen Active Ingredients
FDA proposes expanding sunscreen active ingredient list, signaling new compliance considerations for sunscreen and cosmetic manufacturers.
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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”
Childhood Diabetes Reduction Act warning labels could reshape U.S. food labeling and advertising. Learn what this bill means for your business.
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December 17, 2025
What the New FDA PreCheck Program Means for Drug Manufacturers
FDA PreCheck program aims to boost U.S. drug manufacturing. Learn how it could impact domestic pharmaceutical facilities and compliance steps.
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August 13, 2025
FDA Proposes Compliance Extension And Releases New Tools For Food Traceability
FDA food traceability compliance date may be extended. Learn about the August 2025 proposal, updated FAQs, and tools to prepare your business.
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August 7, 2025
FDA Chemical Screening: What The New EDT Tool Means For Food Safety
FDA’s new EDT tool helps screen chemicals in food for toxicity. Learn how it supports safer food and faster evaluations.
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July 31, 2025
FDA approves gardenia blue as Red No. 3 faces phase-out
FDA approves gardenia (genipin) blue color additive while encouraging a faster phase-out of FD&C Red No. 3. Learn how this impacts your products.
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July 18, 2025
How the SAFE Sunscreen Act Could Change FDA Compliance
Learn how the SAFE Sunscreen Standards Act could impact sunscreen compliance and FDA approvals.
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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
The FDA has extended the comment period for the front-of-package labeling rule. Learn how this affects your business and how to submit feedback.
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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 use this updated system instead of the retired WebTrader platform.
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April 17, 2025
FDA Releases Cosmetic Facility & Product Registration Summary
FDA releases registration and listing data for cosmetic facilities and products under MoCRA. Learn what this means for your compliance.
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March 26, 2025
Self-Affirmed GRAS May End – What It Means for You
The FDA may eliminate self-affirmed GRAS. Learn how this change could affect food ingredient approvals and what steps you should take now.
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March 12, 2025
FDA Updates Guidance on Genome-Edited Foods
Discover the FDA’s latest update on voluntary premarket engagement for genome-edited foods and its implications for developers.
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December 16, 2024
Choosing Between GRAS Notice and Self-Affirmed GRAS
Learn the key differences between GRAS Notice and Self-Affirmed GRAS to ensure FDA compliance and food safety. Find the best approach for your product.
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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