
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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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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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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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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Learn how a new bill may eliminate self-affirmed GRAS and what it means for food ingredient compliance. Stay ahead with expert support.
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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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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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Introduction Sodium reduction in processed foods is no longer optional. It is a critical step for industry players to safeguard
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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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Learn how to meet FDA’s new dietary ingredient notification requirements for dietary supplements with new educational tools.
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Starting June 9, 2025, Class II NHP submissions will no longer be reviewed just based on the date you filed them. Health Canada is updating how it handles licensing applications by applying a new workload management approach, prioritizing submissions based on intent to sell or manufacture in Canada.
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The FDA has officially approved three new food color additives derived from natural sources. These offer a safer alternative to
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FDA unannounced inspections are no longer limited to U.S. facilities. The U.S. Food and Drug Administration (FDA) recently announced an
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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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If your team handles drug product submissions in Canada, there’s a recent update from Health Canada you might want
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Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed.
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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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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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Are you a small or medium-sized business (SME) planning to launch a novel food in the European Union? If so,
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Health Canada has released a draft guidance document on co-packaged drug products, now open for public consultation. The guidance explains
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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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