The FDA has proposed a rule that would introduce mandatory GRAS notification for companies marketing food ingredients under the Generally Recognized as Safe (GRAS) provision.
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Health Canada has finalized the second phase of amendments to modernize medical device establishment licensing in Canada. The amended Medical Devices Regulations were published in the Canada
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Petitioning FDA for a new color additive is a detailed, document-heavy process, and understanding the requirements before you begin makes a meaningful difference in how
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Health Canada has published a new Ministerial Reliance Order, giving the department a formal pathway to speed up select drug reviews by relying on decisions
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Health Canada is consulting on changes to the industrial hemp regulations Canada relies on to license cultivation, processing, and cross-border movement of hemp. The consultation
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The U.S. Food and Drug Administration has published a proposed rule that would create a new registration pathway for drug manufacturers using a hub-and-spoke model, while also
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Health Canada has strengthened its drug and medical device shortage framework. On June 17, 2026, the department published amendments to the Food and Drug Regulations and
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Health Canada opened a public consultation on July 20, 2026, on a draft revised guide covering the quality of natural health products. The consultation closes to
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The U.S. Food and Drug Administration (FDA) has announced two actions targeting outdated authorizations for color additives in food: a final order revoking the use of
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MDEL licence cancellation is one of the more disruptive regulatory outcomes a medical device company can face in Canada. It stops your ability to import, distribute, or
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The U.S. Food and Drug Administration (FDA) has proposed a rule that would close a long-standing registration gap for foreign drug manufacturers, while also simplifying how distributed manufacturing
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Selling a dietary supplement on TikTok Shop sounds like a straightforward channel expansion, until your product listing gets rejected without a clear explanation. The platform
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