MoCRA Safety Substantiation Requirements: What FDA’s Latest Burden Estimate Signals
The U.S. Food and Drug Administration (FDA) has published a Paperwork Reduction Act (PRA) notice that puts a number on
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August 28, 2026
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Why FDA Dietary Exposure Assessments Are Required and What They Mean for Your Product
When your company prepares to bring a new food ingredient into the U.S. market, a dietary exposure assessment is one
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August 26, 2026
FDA’s 2026 AI Medical Device Guidance Signals New Expectations for Manufacturers
The U.S. Food and Drug Administration has released updated guidance for AI-enabled medical devices that reshapes how manufacturers must approach the
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June 18, 2026
Health Canada Ends the FSRN Process and What It Means for Your NHP Site Licence
If you manage regulatory submissions for natural health products, you likely already know that Health Canada ends FSRN acceptance as of February 16, 2026. Health Canada announced this change through Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10.
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February 26, 2026