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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 >>

06

Feb 2023

What is a CRO in Clinical Trials?
What is a CRO in Clinical Trials?
By
A CRO, or Contract Research Organization, is an outsourced service provider that manages clinical trials. CROs are designed to help make research more feasible. It should then come as no […] 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Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices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 >>

28

Nov 2022

FDA Issues Five Warning Letters to Food & Beverage Manufacturers for Products Containing Cannabidiol (CBD)
FDA Issues Five Warning Letters to Food & Beverage Manufacturers for Products Containing Cannabidiol (CBD)
By
On November 21, 2022, the FDA’s Center for Food Safety and Applied Nutrition issued warning letters to five manufacturers of food and beverages containing cannabidiol (CBD). These letters mark the […] Read More >>

24

Nov 2022

What is Real-World Evidence?
What is Real-World Evidence?
By
Real-world data (RWD) and real-world evidence (RWE) are becoming an integral part of health care decisions such as in the approving process, in clinical practice, in generating innovative, and new […] Read More >>

23

Nov 2022

FDA Issues Warning Letters to Seven Dietary Supplement Manufacturers for Using Drug Claims
FDA Issues Warning Letters to Seven Dietary Supplement Manufacturers for Using Drug Claims
By
On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health. The dietary […] Read More >>

14

Nov 2022

FDA Concludes that Nicotinamide Mononucleotide (NMN) Cannot be Marketed or Sold in Dietary Supplements
FDA Concludes that Nicotinamide Mononucleotide (NMN) Cannot be Marketed or Sold in Dietary Supplements
By
The FDA recently published responses to several new dietary ingredient notifications (NDIN) submitted for nicotinamide mononucleotide (most notably the November 8, 2022 response to Inner Mongolia Kingdomway Pharmaceutical Ltd. “Kingdomway”). […] Read More >>

03

Nov 2022

Monkeypox Testing – U.S Pathways to Licensing
Monkeypox Testing – U.S Pathways to Licensing
By
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. Usually endemic to regions of central and […] Read More >>

25

Oct 2022

GRAS, New Dietary Ingredients (NDI’s), Old Dietary Ingredients (ODI’s), and Food Additives – Is Your Product Classified Correctly?
GRAS, New Dietary Ingredients (NDI’s), Old Dietary Ingredients (ODI’s), and Food Additives – Is Your Product Classified Correctly?
By
To be used in foods and dietary supplements, ingredients must: be determined to be Generally Recognized as Safe (GRAS), be approved as a New Dietary Ingredient (NDI), be considered an […] Read More >>

21

Oct 2022

What is the Difference Between a DIN and an NPN?
What is the Difference Between a DIN and an NPN?
By
Bringing a drug or a natural health product to market in Canada involves applying for an 8-digit numerical code, called a DIN for drugs, or an NPN for natural health […] Read More >>

22

Sep 2022

Monkeypox Testing – Canadian Pathways to Licensing
Monkeypox Testing – Canadian Pathways to Licensing
By
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. While appearing similar to smallpox, it is […] 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 >>

26

Jul 2022

Changes to Natural Health Product Regulations (NHPR) Labelling Requirements
Changes to Natural Health Product Regulations (NHPR) Labelling Requirements
By
New labelling requirements announced by Health Canada in Canada Gazette, Part II, Volume 156, Number 14 titled “Regulations Amending the Natural Health Products Regulations” have come into effect as of […] Read More >>

12

Jul 2022

How Much Does it Cost to Get an MDEL & MDL Approval?
How Much Does it Cost to Get an MDEL & MDL Approval?
By
The cost to obtain an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada depends on the medical device’s classification. In this blog, we will break down […] Read More >>

05

Jul 2022

What is Bioanalytical Testing?
What is Bioanalytical Testing?
By
Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids. Bioanalytical testing involves using a validated bioanalytical method for the […] 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 >>

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