1-866-647-3279

20

Aug 2026

How to Prepare a Self GRAS Dossier for FDA Review
How to Prepare a Self GRAS Dossier for FDA Review
By
At a Glance A well-prepared self-affirmed GRAS dossier may already contain much of the scientific information needed to support an FDA GRAS notice. However, converting an existing dossier for FDA […] Read More >>

19

Aug 2026

Clinical Supply Chain Oversight for Live Biotherapeutic Trials: Protecting Product Viability from Manufacturing to Patient
Clinical Supply Chain Oversight for Live Biotherapeutic Trials: Protecting Product Viability from Manufacturing to Patient
By
At a Glance Live Biotherapeutic Products (LBPs) are transforming therapeutic development, with clinical programs expanding across gastrointestinal disorders, metabolic disorders, immunology, oncology, and rare conditions. Unlike conventional pharmaceutical Read More >>

14

Aug 2026

What Is Vanessa’s Law and How Does It Impact Therapeutic Products in Canada?
What Is Vanessa’s Law and How Does It Impact Therapeutic Products in Canada?
By
At a Glance Vanessa’s Law, formally known as the Protecting Canadians from Unsafe Drugs Act, strengthened Health Canada’s authority to identify and respond to safety risks associated with therapeutic products […] Read More >>

14

Aug 2026

Postbiotics vs. Probiotics: Regulatory and Clinical Differences
Postbiotics vs. Probiotics: Regulatory and Clinical Differences
By
Abstract Probiotics and postbiotics are both increasingly used in microbiome-focused health products, but the regulatory and clinical considerations surrounding them can differ substantially. Probiotics depend on live microorganisms, making strain [&hellip Read More >>

14

Aug 2026

Health Canada Publishes New Guidance for Non-Prescription Drug Market Authorization in Canada
Health Canada Publishes New Guidance for Non-Prescription Drug Market Authorization in Canada
By
At a Glance Health Canada has released a new guidance document, How to apply for market authorization for a non-prescription drug in Canada, providing industry with its first comprehensive roadmap […] Read More >>

11

Aug 2026

FDA Proposes Mandatory GRAS Notification: What Food Manufacturers Need to Know
FDA Proposes Mandatory GRAS Notification: What Food Manufacturers Need to Know
By
At a Glance On August 10, 2026, HHS announced that FDA had issued a proposed rule that would replace the current voluntary GRAS notification program with a mandatory notification requirement […] Read More >>

06

Aug 2026

What Is NHP Stability Testing? Understanding Shelf Life, Expiry Dates, and Health Canada Requirements
What Is NHP Stability Testing? Understanding Shelf Life, Expiry Dates, and Health Canada Requirements
By
At a Glance Stability testing is the process of evaluating how the quality of a dietary supplement or Natural Health Product (NHP) changes over time under defined storage conditions. The […] Read More >>

06

Aug 2026

AI in Regulatory Intelligence and Literature Reviews: Where It Helps, and Where It Falls Short
AI in Regulatory Intelligence and Literature Reviews: Where It Helps, and Where It Falls Short
By
At a Glance AI literature review tools can help regulatory and scientific teams search, screen, organize, and summarize growing volumes of information. Their greatest value lies in narrow, repetitive tasks […] Read More >>

06

Aug 2026

Adverse Event Monitoring in Probiotic Clinical Trials: What Sponsors Need to Get Right
Adverse Event Monitoring in Probiotic Clinical Trials: What Sponsors Need to Get Right
By
At a Glance While many commercially available probiotics have a well-documented history of safe use in healthy populations, clinical trials evaluating live biotherapeutic products (LBPs) or probiotic dietary supplements are […] Read More >>

31

Jul 2026

Does a Proprietary Ingredient Blend Need Its Own GRAS Conclusion?
Does a Proprietary Ingredient Blend Need Its Own GRAS Conclusion?
By
Abstract Introduction Developing a proprietary blend can create an important regulatory question: if every component is already Generally Recognized as Safe (GRAS), can the ingredients be combined under one existing […] Read More >>

31

Jul 2026

Cosmetic Claims in Canada: What Cosmetic Companies Can (and Can’t) Say
Cosmetic Claims in Canada: What Cosmetic Companies Can (and Can’t) Say
By
At a Glance Marketing claims are one of the most important factors determining how a cosmetic product is regulated in Canada. While cosmetics may claim to cleanse, beautify, moisturize, or […] Read More >>

31

Jul 2026

IND Requirements for Live Biotherapeutic Products: What Sponsors Need to Know
IND Requirements for Live Biotherapeutic Products: What Sponsors Need to Know
By
Abstract Live Biotherapeutic Products (LBPs) are biological products that contain live organisms, are applicable to the prevention, treatment, or cure of a human disease or condition, and are not vaccines. […] Read More >>

24

Jul 2026

FDA Front-of-Package Nutrition Labelling Is Still Moving Forward: What Food Manufacturers Need to Know
FDA Front-of-Package Nutrition Labelling Is Still Moving Forward: What Food Manufacturers Need to Know
By
Abstract Although the proposed rule has been quieter than many expected, recent FDA communications confirm that Front-of-Package (FOP) nutrition labelling remains very much on the agency’s agenda. Here’s what has […] Read More >>

21

Jul 2026

Health Canada’s New Draft Quality Guide for Natural Health Products: Open for Consultation
Health Canada’s New Draft Quality Guide for Natural Health Products: Open for Consultation
By
At a Glance Health Canada has released a draft Quality of Natural Health Products Guide for consultation, proposing the most significant update to NHP quality guidance since the finalized Good […] Read More >>

21

Jul 2026

Can a U.S. GRAS Ingredient be Sold in the European Union?
Can a U.S. GRAS Ingredient be Sold in the European Union?
By
Abstract For ingredient manufacturers expanding internationally, achieving Generally Recognized as Safe (GRAS) status in the United States is often viewed as a significant regulatory milestone. However, GRAS does not authorize […] Read More >>

16

Jul 2026

FDA Delays Proposed GRAS Final Rule to December 2026: What Food Manufacturers Should Know
FDA Delays Proposed GRAS Final Rule to December 2026: What Food Manufacturers Should Know
By
Originally expected earlier this year, FDA’s proposed overhaul of the Generally Recognized as Safe (GRAS) notification process has now been pushed to December 2026. While the timeline has shifted, the […] Read More >>

15

Jul 2026

Synbiotics: Regulatory Classification and Clinical Trial Considerations
Synbiotics: Regulatory Classification and Clinical Trial Considerations
By
Abstract Synbiotics represent an increasingly sophisticated approach to microbiome-focused products by combining live microorganisms with substrates designed to support beneficial microbial activity. However, regulatory classification and evidence requirem Read More >>

15

Jul 2026

Postbiotics: The “Non-Live” Microbe Trend Reshaping Functional Health Products
Postbiotics: The “Non-Live” Microbe Trend Reshaping Functional Health Products
By
Abstract Postbiotics are emerging as a significant new category of microbiome-focused products, offering potential advantages over traditional probiotics through improved stability, simplified manufacturing, and greater formulation flexibility. However, de Read More >>

15

Jul 2026

Does GRAS Status Matter in Canada?
Does GRAS Status Matter in Canada?
By
Abstract U.S. GRAS status is an important safety milestone, but it does not authorize an ingredient for sale in Canada. Instead, Health Canada evaluates ingredients under its own regulatory framework, […] Read More >>

14

Jul 2026

Front-of-Package Nutrition Labelling Is Now Enforceable in Canada: Who Must Comply and What Happens If You Don’t?
Front-of-Package Nutrition Labelling Is Now Enforceable in Canada: Who Must Comply and What Happens If You Don’t?
By
Abstract Canada’s Front-of-Package (FOP) nutrition labelling requirements are now fully enforceable. Since January 1, 2026, most prepackaged foods imported, manufactured, or packaged at retail in Canada must display the prescribed […] Read More >>

    Menu
    Online Learning
    Subscribe

    Stay up to date on regulatory and compliance updates, news, and events!

      © dicentra. All Rights Reserved.
      Privacy Statement | Terms & Conditions