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26

Jun 2026

Health Canada Finalizes Phase 2 MDEL Modernization: What Importers Need to Know
Health Canada Finalizes Phase 2 MDEL Modernization: What Importers Need to Know
By
Health Canada has finalized the second phase of its modernization of the Medical Device Establishment Licence (MDEL) framework, publishing amendments to the Medical Devices Regulations in the Canada Gazette, Part […] Read More >>

12

Jun 2026

AI-Enabled Medical Devices: Regulatory Expectations Across the Product Lifecycle
AI-Enabled Medical Devices: Regulatory Expectations Across the Product Lifecycle
By
Artificial intelligence is changing the way regulators evaluate medical devices, particularly where software functionality influences clinical decision-making or adapts over time. While software regulation is not new, machine learning introduces […] Read More >>

28

Apr 2026

Monitoring Safety in Probiotic Clinical Studies: Key Considerations
Monitoring Safety in Probiotic Clinical Studies: Key Considerations
By
Probiotics are widely regarded as safe in healthy populations. However, as clinical research moves toward targeted, high-potency, and therapeutic outcomes, safety monitoring must evolve. Living organisms interact dynamically with the […] Read More >>

20

Apr 2026

How AI is Regulated Across FDA, Health Canada, and the EU
How AI is Regulated Across FDA, Health Canada, and the EU
By
AI is already part of your regulatory process AI isn’t coming to life sciences—it’s already here. It’s being used to screen ingredients, draft labels, monitor claims, summarize safety data, assemble […] Read More >>

17

Apr 2026

AI in Pharmacovigilance: Where Automation Meets Regulatory Accountability
AI in Pharmacovigilance: Where Automation Meets Regulatory Accountability
By
AI is entering the most failure-prone part of the lifecycle Pharmacovigilance has always been one of the most operationally complex—and failure-prone—areas of the regulatory lifecycle. It depends on the timely […] Read More >>
“FDA Cosmetic Safety and Modernization Act” Introduced in Congress; Juxtaposed with “Personal Care Products Safety Act”
December 8, 2017 By
On October 25th, 2017 during the 115th US Congress Meeting, Senator Orrin Hatch (Representative of Utah) introduced to the US Senate the “FDA Cosmetic Safety and Modernization Act”. The declared […] Read More >>
If You Think the FDA’s cGMPs Don’t Apply to You, Think Again!
April 30, 2012 By
By Heather Van Blarcom General Counsel & Senior Regulatory Specialist – USA If your name is on the label of a dietary supplement product that you market and distribute, you […] Read More >>
Kava in Canada
April 30, 2012 By
By David Miller, BSc, ND NHP Scientific Regulatory Associate Kava (Piper methysticum; kava kava) has traditionally been used as an anxiolytic by western herbalists (Felter and Lloyd 1898) for over […] Read More >>

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