
FDA’s Proposed Rule Reshapes Registration for Hub-and-Spoke Drug Manufacturers
The U.S. Food and Drug Administration has published a proposed rule that would create a new registration pathway for drug manufacturers using
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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
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For nearly three decades, companies introducing a new food or ingredient use into the U.S. market have had a choice:
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The U.S. Food and Drug Administration (FDA) has approved a new sunscreen ingredient for use in over-the-counter products sold in
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Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) has opened a Health Canada monograph consultation for two botanicals: black
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Health Canada has confirmed it is moving forward with amendments to NHP labelling requirements in Canada, with draft regulations now
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Health Canada is moving to answer a question the industry has been pressing for years: why should Canada conduct a
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Health Canada has launched a new national consultation that could reshape how infant foods for special dietary purposes are assessed
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EFSA’s transparency rules for novel foods are reshaping how businesses approach regulatory compliance in the European Union. If you’re planning to introduce
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After years of uncertainty and legal disputes, the U.S. Food and Drug Administration (FDA) declared on September 29, 2025, that
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On September 4, 2025, Health Canada released Version 4.0 of the Good Manufacturing Practices (GMP) Guide for Natural Health Products
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Businesses in Canada have long raised concerns about red tape in Health Canada regulations, from outdated rules to lengthy approval
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Health Canada has made an important decision regarding grape seed extract, now approved for use as a supplemental ingredient in
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