Health Canada Consults on Changes to Industrial Hemp Regulations
Health Canada is consulting on changes to the industrial hemp regulations Canada relies on to license cultivation, processing, and cross-border
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July 31, 2026
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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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July 30, 2026
Health Canada Expands Its Drug and Medical Device Shortage Framework
Health Canada has strengthened its drug and medical device shortage framework. On June 17, 2026, the department published amendments to
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July 28, 2026
Health Canada Opens Consultation on NHP Quality Expectations for 2026
Health Canada opened a public consultation on July 20, 2026, on a draft revised guide covering the quality of natural health
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July 24, 2026
Color Additives in Food Face Removal as FDA Revokes Outdated Authorizations
The U.S. Food and Drug Administration (FDA) has announced two actions targeting outdated authorizations for color additives in food: a final
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July 22, 2026
FDA Proposes Rule to Close Registration Gap for Foreign Drug Manufacturers
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
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July 15, 2026
FDA Mandatory GRAS Notification Rule Could Reshape Food Ingredient Compliance by Year End
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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July 10, 2026
Health Canada Launches Cost-Benefit Analysis Survey on Natural Health Product Red Tape Reduction
Health Canada has opened a cost-benefit analysis survey inviting natural health product companies and industry associations to gather input on
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July 8, 2026
FDA Approves New Sunscreen Ingredient Expanding Consumer Options
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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July 7, 2026
FDA Flags Data Integrity Issues at Device Testing Labs
The U.S. Food and Drug Administration (FDA) has issued notifications raising FDA data integrity concerns about medical device testing labs, signaling that the
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July 6, 2026
FDA Issues Guidance Exempting Certain Unclassified Medical Devices from 510(k) Premarket Review
The U.S. Food and Drug Administration has released guidance clarifying regulatory expectations for unclassified medical devices and 510(k) premarket notification requirements, formally
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July 3, 2026
Health Canada Removes FPS Submission Requirement for NHP Product Licence Applications
Health Canada has officially eliminated the finished product specification (FPS) submission requirement for Class II and Class III NHP product
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June 23, 2026
Health Canada Launches Monograph Consultation for Black Cumin and Tongkat Ali
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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June 20, 2026
FDA Advances Post-Market Review of Phthalates Used in Food Contact Materials
The U.S. Food and Drug Administration (FDA) has taken a significant step forward in its post-market reassessment of phthalates used
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June 19, 2026
FDA’s 2026 AI Medical Device Guidance Signals New Expectations for Manufacturers
The U.S. Food and Drug Administration has released updated guidance for AI-enabled medical devices that reshapes how manufacturers must approach the
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June 18, 2026
Health Canada Amends Prescription Drug List to Require a Prescription for Pediatric Melatonin Use
Health Canada has amended the Prescription Drug List (PDL) to require a prescription for all sleep-related use of melatonin in
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June 10, 2026
FDA Launches One-Day Inspectional Assessments to Strengthen Inspection Oversight
The U.S. Food and Drug Administration announced on May 6, 2026, that it is piloting a new class of shorter,
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May 20, 2026
FDA’s Food Chemical Safety Assessment Program Is Now Final: BHT and ADA Are First Up for Review
On May 12, 2026, the U.S. Food and Drug Administration finalized its new food chemical safety assessment program and simultaneously launched formal
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May 13, 2026
Health Canada Signals Further Extension to NHP Labelling Requirements Compliance Timeline
Health Canada has confirmed it is moving forward with amendments to NHP labelling requirements in Canada, with draft regulations now
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May 12, 2026
FDA OMUFA Arrears Lists Updated: What OTC Drug Facility Owners Need to Know
On May 11, 2026, the U.S. Food and Drug Administration published its latest update to the Over-the-Counter Monograph Drug User
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May 11, 2026
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July 14, 2025