
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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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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Recent regulatory activity in the United States is drawing renewed attention to sunscreen compliance. In a new announcement, the FDA
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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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Learn the difference between a GRAS Notice and self-affirmed GRAS, including risks, benefits, and how to prepare for regulatory changes.
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The difference between GRAS and FEMA GRAS is a common point of confusion for companies working with food and flavor ingredients. When
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FDA GRAS projects can feel overwhelming, especially when you are trying to balance timelines, research needs, and budget pressures at
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Building your safety narrative for a GRAS notice begins with toxicological studies for GRAS conclusion, and this foundation is one of the
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Introduction: Why EFSA Novel Food Clinical Studies Matter Bringing a novel food to the European market requires more than innovation.
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Event Dates: October 27–30, 2025Location: Mandalay Bay, Las Vegas, USA SupplySide Connect Las Vegas 2025 is the leading event for
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Event Dates: September 17–18, 2025 Location: International Center, Hall 2, Mississauga, ON Join Quality Smart Solutions at Pets Canada 2025, Canada’s
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The de minimis rule has long been a key part of U.S. customs policy. It allowed companies to import low-value
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The FDA has released a new tool called the Expanded Decision Tree (EDT), which is designed to support chemical safety
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If you’re finding it difficult to navigate the GRAS process, you’re not alone. Whether you’re introducing a new food ingredient
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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 eczema product market continues to grow as consumer demand increases, but that doesn’t mean you can jump in without
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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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What is NPN? Learn how to get approval for your natural health product and stay compliant with Canadian regulations.
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If you’re trying to bring a food or supplement product to both the Canadian and US markets, you’ve probably already
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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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Starting March 2025, Health Canada requires all cosmetic notifications to include a Canadian Agent. Learn what this means for your business.
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Changes are on the horizon for caffeine as a supplemental ingredient, and they could directly impact your business. Whether you
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Are Your Supplemental Ingredients Compliant? Canada’s New Rules Explained If your business sells supplemented foods in Canada, major regulatory updates
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The regulatory landscape for NHP labelling is evolving, with businesses facing increasing pressure to comply with Health Canada’s updated regulations. Initially
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The introduction of Bill 96 in Quebec brings new challenges for businesses across Canada. As a result, this legislation emphasizes
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Navigating the FDA compliance process for shilajit can be challenging, especially if you’re new to the regulatory landscape. As shilajit
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Navigating Health Canada’s rules for probiotic health claims can feel overwhelming, especially with the growing demand for these products. Businesses
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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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Are you looking to bring your infant formula to the Canadian market? Successfully navigating Canada infant formula registration is essential
... Read moreWhen it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The
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If you’re looking to grow your e-commerce business, learning how to sell on Amazon Canada is a smart move. With
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Understanding the differences between GRAS and NDI is essential for any company developing food ingredients or dietary supplements in the
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If you’re selling natural health products in Canada, understanding NHPID and NPN is essential. These tools from Health Canada determine
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