1-866-647-3279

03

Aug 2023

FDA Announces Findings from Voluntary Pilot Program Evaluating Third-Party Food Safety Standards
FDA Announces Findings from Voluntary Pilot Program Evaluating Third-Party Food Safety Standards
By
On July 17, 2023, the FDA announced the successful conclusion of its voluntary pilot program to evaluate the alignment of third-party food safety audit standards with relevant FDA regulations. The […] Read More >>

30

Mar 2023

Health Canada Updates Policy on Listeria monocytogenes in Ready-to-Eat Foods
Health Canada Updates Policy on Listeria monocytogenes in Ready-to-Eat Foods
By
On March 27, 2023, Health Canada updated the “Policy on Listeria monocytogenes in Ready-to-Eat Foods”. This new policy will come into effect on October 1, 2023. Until then, the 2011 […] Read More >>

27

Mar 2023

Reminder: VQIP Application Due Date for Importers is May 31, 2023
Reminder: VQIP Application Due Date for Importers is May 31, 2023
By
This is a reminder to all importers wishing to certify food products under the Voluntary Qualified Importer Program (VQIP) for fiscal year (FY) 2024 that the VQIP Application due date […] Read More >>

15

Mar 2023

FDA Launches New Ingredient Directory for Dietary Supplements
FDA Launches New Ingredient Directory for Dietary Supplements
By
On March 6, 2023, the Food and Drug Administration (FDA) launched a new directory of ingredients used in dietary supplements. The directory will be a “one-stop shop” for ingredient information […] Read More >>

09

Mar 2023

FDA Proposes New Guidance for Labeling of Plant-Based Milk Alternatives
FDA Proposes New Guidance for Labeling of Plant-Based Milk Alternatives
By
On February 22, 2023, the Food and Drug Administration (FDA), released draft guidance regarding the labeling of plant-based milk alternatives. The draft guidance, which provides industry with guidance on labeling […] Read More >>

23

Feb 2023

What are the Seven Changes to the Nutrition Facts Label?
What are the Seven Changes to the Nutrition Facts Label?
By
Back in 2016, the FDA published new requirements for the Nutrition Facts Table (or NFT) on packaged foods. This update was made to reflect new scientific information, linking together diet […] Read More >>

17

Feb 2023

Proposed Changes to the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Proposed Changes to the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
By
On December 22, 2022, Health Canada opened consultation on a proposal to amend the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs). The […] Read More >>

17

Feb 2023

Health Canada Draft Guidance Document: On the Collection and Analysis of Disaggregated Data in Clinical Trials
Health Canada Draft Guidance Document: On the Collection and Analysis of Disaggregated Data in Clinical Trials
By
On December 17, 2022, Health Canada pre-published in Canada Gazette Part I, amendments to the Food and Drug Regulations (FDR). Health Canada is recommending new provisions for new drug submissions […] Read More >>

17

Feb 2023

Health Canada Draft Guidance Document: Management of Rolling Reviews for Drug Submissions
Health Canada Draft Guidance Document: Management of Rolling Reviews for Drug Submissions
By
Health Canada is proposing new amendments to the Food and Drug Regulations and Medical Devices Regulations. Part of these amendments include “new provisions that enable the rolling review of a […] Read More >>

17

Feb 2023

Health Canada Draft Guidance Document: Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use
Health Canada Draft Guidance Document: Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use
By
On December 21, 2022, Health Canada opened a consultation on a proposal to amend the labelling of pharmaceutical drugs for human use guidance document. The amendments that have been proposed […] Read More >>

15

Feb 2023

FDA Concludes that a New Regulatory Pathway is Needed for Cannabidiol
FDA Concludes that a New Regulatory Pathway is Needed for Cannabidiol
By
On January 26, 2023, Principal Deputy Commissioner Janet Woodcock released a statement regarding the current state of cannabidiol (CBD) regulation by the FDA and a growing need for a “new […] Read More >>

06

Feb 2023

FDA Proposes Changes to the Food Program in Order to Protect Food Safety
FDA Proposes Changes to the Food Program in Order to Protect Food Safety
By
On January 31, 2023, the Commissioner of the Food and Drug Administration, Dr. Robert Califf, announced a proposal to overhaul the human foods program to protect food safety. The statement, […] Read More >>

01

Feb 2023

Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
By
Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating medical devices. This is […] Read More >>

23

Jan 2023

FDA Proposes New Rule for Investigational New Drug Applications. Open for Consultation Until March 9, 2023.
FDA Proposes New Rule for Investigational New Drug Applications. Open for Consultation Until March 9, 2023.
By
The FDA has recently announced a proposal to amend the current Investigational New Drug (IND) application regulations. The proposal involves 2 exemptions for clinical investigations involving lawfully marketed foods (including […] Read More >>

29

Dec 2022

FTC Issues Dietary Supplement Claims Guidance for First Time since 1998
FTC Issues Dietary Supplement Claims Guidance for First Time since 1998
By
On December 20, 2022, the Federal Trade Commission (FTC) published “Health Products Compliance Guidance” for advertising and marketing health claims. The guidance document replaces “Dietary Supplements: An Advertising Guide for […] Read More >>

26

Jul 2022

Health Canada Introduces New Regulatory Framework for the Sale of Supplemented Foods
Health Canada Introduces New Regulatory Framework for the Sale of Supplemented Foods
By
On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR), introducing new regulations for supplemented foods as a category. These new regulations continue to protect […] Read More >>

15

Jun 2022

How Much Does it Cost to Get a 510(K) Approval?
How Much Does it Cost to Get a 510(K) Approval?
By
This blog is meant to be an overview of the average costs associated with bringing a medical device to market under normal circumstances. Depending on when you are reading this […] Read More >>

31

May 2022

ALERT: New European Union In Vitro Diagnostics Regulations (EU IVDR) to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC)
ALERT: New European Union In Vitro Diagnostics Regulations (EU IVDR) to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC)
By
The new European Union In Vitro Diagnostics Regulations (EU IVDR) entered into application on May 26, 2022, to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC). Manufacturers, authorized representatives, importers, and […] Read More >>

13

May 2022

EU In Vitro Diagnostic Medical Device Regulation
EU In Vitro Diagnostic Medical Device Regulation
By
In vitro diagnostic medical devices contain a broad spectrum of devices that test biological samples to determine the status of one’s health, from self-tests for pregnancy, to blood glucose tests […] Read More >>

16

Jul 2020

The CFIA’s July 15, 2020 compliance date has come, and gone – what does this mean for my business?
The CFIA’s July 15, 2020 compliance date has come, and gone – what does this mean for my business?
By
On July 15, 2020, the next scheduled compliance date for the Safe Food for Canadians Act & Regulations came into effect for businesses in the manufactured food sector. The compliance […] 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