If you’re in the business of nicotine replacement therapies, major regulatory changes are now in place.
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Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find
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Learn how to navigate Canada’s strict infant formula registration process and ensure full compliance with Health Canada’s regulations.
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Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input The Natural and Non-Prescription Health Products Directorate (NNHPD) invites industry stakeholders to provide
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Introduction Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing Practices (GMP) requirements. The FDA
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Navigating Health Canada’s drug submission pathways can be daunting. How do you know which pathway—ANDS, SNDS, or NDS—best suits your product? Each submission route holds
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Two pivotal documents in this regulatory landscape, the Health Canada Drug Monograph and Product Monograph, hold distinct roles and purposes. Keep reading to learn more.
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FDA User Fees for Fiscal Year 2025 (FY2025) The FDA’s user fees for FY2025, which runs from October 1, 2024, to September 30, 2025, apply
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Simplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special labeling symbols on certain food
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GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and avoiding recalls In light of
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The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg products, a critical development for
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The NNHPD Opens Consultation on Batch 4 Through new guidelines, stakeholders are invited to shape the future of homeopathic and topical health products. The Natural
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