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26

Jun 2026

AI Hallucinations: Why Regulators Are Paying Attention
AI Hallucinations: Why Regulators Are Paying Attention
By
Regulatory and oversight concern around AI hallucinations is not centered only on intentional misuse, but on the introduction of unverifiable, unsupported, or fabricated information into regulated workflows. As organizations increasingly […] Read More >>

26

Jun 2026

FDA QMSR Requirements in 2026: What Medical Device Manufacturers Need to Know
FDA QMSR Requirements in 2026: What Medical Device Manufacturers Need to Know
By
On February 2, 2026, the FDA’s revised Quality Management System Regulation (QMSR) officially became effective, replacing the long-standing Quality System (QS) Regulation framework under 21 CFR Part 820. While the […] Read More >>

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 >>

17

Jun 2026

Health Canada Removes FPS Submission Requirement for NHP Applications
Health Canada Removes FPS Submission Requirement for NHP Applications
By
Health Canada has released Natural Health Product Licensing Bulletin No.11 introducing a significant operational change to the way Finished Product Specifications (FPS) are handled for Natural Health Product (NHP) product […] 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 >>

31

May 2026

Is Collagen Generally Recognized as Safe (GRAS) in the United States?
Is Collagen Generally Recognized as Safe (GRAS) in the United States?
By
Collagen continues to dominate the functional ingredient market across foods, beverages, supplements, and beauty-from-within products. From protein powders and ready-to-drink beverages to gummies and nutrition bars, collagen ingredients are now […] Read More >>

29

May 2026

GRAS for GLP-1 Inspired Supplements: Regulatory Strategy & Ingredient Considerations
GRAS for GLP-1 Inspired Supplements: Regulatory Strategy & Ingredient Considerations
By
As GLP-1 receptor agonist drugs like Ozempic®, Wegovy®, and Mounjaro® continue to dominate conversations around weight management and metabolic health, supplement companies are increasingly exploring ingredients that may support the […] Read More >>

29

May 2026

What GRAS Means For Pet Foods in the United States
What GRAS Means For Pet Foods in the United States
By
Pet food innovation is moving quickly across the United States. From novel proteins and functional ingredients to fermentation-derived compounds and upcycled materials, manufacturers are continuing to develop increasingly sophisticated products […] Read More >>

11

May 2026

Natural Health Products Labelling Compliance Extension: What Industry Needs to Know
Natural Health Products Labelling Compliance Extension: What Industry Needs to Know
By
Health Canada has announced a significant update regarding the implementation timeline for the 2022 amendments to the Natural Health Products Regulations (NHPR) labelling requirements. Under the latest Natural Health Product […] Read More >>

29

Apr 2026

GRAS vs NDI: What Ingredient Manufacturers Need to Know
GRAS vs NDI: What Ingredient Manufacturers Need to Know
By
Why this distinction matters more than ever For companies developing ingredients for the U.S. market, one question comes up early—and often: Should this ingredient go the GRAS route, or require […] Read More >>

28

Apr 2026

Prebiotic vs Probiotic Claims: Regulatory Considerations
Prebiotic vs Probiotic Claims: Regulatory Considerations
By
As the gut microbiome continues to gain attention across food, natural health products (NHPs), and dietary supplements, prebiotic and probiotic claims have become a central focus for product development and […] 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 >>

28

Apr 2026

Designing Placebo Controls for Probiotic Trials: Key Considerations
Designing Placebo Controls for Probiotic Trials: Key Considerations
By
Placebo-controlled studies remain the gold standard for demonstrating efficacy in clinical research. However, in probiotic trials, designing an appropriate placebo is far from straightforward. Unlike conventional pharmaceuticals, probiotics are living [&he Read More >>

24

Apr 2026

Health Canada Reclassifies Sports Electrolyte Products as Foods: What Industry Needs to Know
Health Canada Reclassifies Sports Electrolyte Products as Foods: What Industry Needs to Know
By
Health Canada has announced a significant regulatory update affecting sports electrolyte products, formally transitioning them from the Natural Health Product (NHP) framework to the food regulatory framework. This change reflects […] Read More >>

24

Apr 2026

Dietary Supplement cGMPs 2026: FDA Enforcement Is Rising — and Most Companies Are Not Ready
Dietary Supplement cGMPs 2026: FDA Enforcement Is Rising — and Most Companies Are Not Ready
By
Register for Dietary Supplement cGMP Online Training | 21 CFR Part 111 There have been no major structural changes to 21 CFR Part 111 in recent years. However, focusing on […] Read More >>

23

Apr 2026

State-Level GRAS Disclosure Bills: What They Mean for Food Manufacturers
State-Level GRAS Disclosure Bills: What They Mean for Food Manufacturers
By
State-level scrutiny of Generally Recognized as Safe (GRAS) substances is no longer limited to New York. While New York’s Food Safety and Chemical Disclosure Act has drawn significant attention because […] Read More >>

21

Apr 2026

GRAS Certification: What It Really Means (and Why it Doesn’t Exist)
GRAS Certification: What It Really Means (and Why it Doesn’t Exist)
By
If you’ve been researching how to bring a food ingredient to market in the United States, you’ve likely come across the term “GRAS certification.” It’s a phrase that sounds official—but […] Read More >>

21

Apr 2026

FDA Reverses Position on NMN: A New Pathway for Dietary Supplments
FDA Reverses Position on NMN: A New Pathway for Dietary Supplments
By
The U.S. Food and Drug Administration (FDA) has officially reversed its position on beta-nicotinamide mononucleotide (NMN), concluding that the ingredient is not excluded from the definition of a dietary supplement. […] 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 >>

20

Apr 2026

AI in Clinical Trials: Current Regulatory Expectations
AI in Clinical Trials: Current Regulatory Expectations
By
What sponsors need to know today AI isn’t a future consideration in clinical research—it’s already embedded in how trials are designed, executed, and monitored. From protocol optimization and patient recruitment […] Read More >>

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