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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Health Canada Draft Guidance Document: Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use
Health Canada Draft Guidance Document: Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use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Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices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 >>

09

Apr 2020

Temporary FDA Policy for Nutrition Labeling of Packaged Food
Temporary FDA Policy for Nutrition Labeling of Packaged Food
By
To facilitate the distribution of food during the COVID-19 pandemic, the US FDA recently issued a guidance document titled “Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health [&hell Read More >>

03

Apr 2020

New FDA Guidance Updates on Gowns, Gloves and Other Apparel in response to COVID-19
New FDA Guidance Updates on Gowns, Gloves and Other Apparel in response to COVID-19
By
The Food and Drug Administration (FDA) recently published a new guidance document to help expand the availability of surgical apparel, including gowns, hoods, and surgical & patient examination gloves, in […] Read More >>

27

Mar 2020

FDA & EPA – Pathways for Products in Response to COVID-19 Product Shortages
FDA & EPA – Pathways for Products in Response to COVID-19 Product Shortages
By
The COVID-19 pandemic has precipitated an unprecedented public health situation in the United States of America, disrupting supply chains and creating shortages of products aimed at preventing infection. As a […] Read More >>

13

Mar 2020

Fight Back Against Coronavirus – How to Get Your Human-Use Antiseptic Drugs To Market
Fight Back Against Coronavirus – How to Get Your Human-Use Antiseptic Drugs To Market
By
With the recent announcement that Coronovirus has gone pandemic, consumers are flooding supermarkets, and preparing for indeterminate periods of self-isolation. All the while the marketplace is reeling, seeing demand for […] Read More >>

13

Mar 2020

Recommendations for Infection Prevention from Regulatory Bodies
Recommendations for Infection Prevention from Regulatory Bodies
By
Based on what is currently known about the novel coronavirus (COVID-19) and similar coronaviruses that cause SARS (Sudden Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome), the most common […] Read More >>
Pending Regulatory Changes that Impact your Business
January 21, 2016 By
STAY ALERT AND AWARE OF PENDING CHANGES THAT MAY IMPACT YOUR BUSINESS How does the Food Safety Modernization Act affect your business? What do the latest guidance documents say? What are […] Read More >>
SPECIAL ALERT: NHP Compliance and Enforcement Transition: Phase I ending December 1, 2013
November 8, 2013 By
November 8, 2013 Phase I of the NHP Compliance and Enforcement transition period is ending December 1, 2013. Companies have been advised to ensure that they are familiar with and […] Read More >>
dicentra’s Regulatory Webinar – Q1: March 26, 2013
March 26, 2013 By
March 26, 2013: dicentra conducted its first webinar of 2013. Critical American and Canadian updates including FDA’s proposed rules to amend cGMPs for food facilities under FSMA, the FDA’s Draft […] Read More >>
Update: Oil of Oregano and Carvacrol
March 4, 2013 By
NHPD revises maximum daily limit of carvacrol for natural health products containing Oil of Oregano as a medicinal ingredient. Oil of oregano, derived from the species of Origanum spp., is […] Read More >>

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