MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023
PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023. The
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March 7, 2023
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MDR Amendments COVID-19 Medical Devices Importing & Sales
Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose, treat,
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March 7, 2023
Health Canada Labelling & Cosmetic Notification changes in 2023
Introduction: The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following
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March 3, 2023
FDA Draft Guidance Labeling Plant Based Milk Alternatives in 2023
Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of
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February 22, 2023
Health Canada Latest Draft Guidance (Biologic Regulations, Drug Labelling, NDS/ANDS & Drug Submissions Rolling Reviews)
Introduction: Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide
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February 22, 2023
FDA to tighten regulatory process around CBD food & supplements
Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling
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January 27, 2023
Health Canada Medical Device Regulations (MDL, MDEL, SaMD)
Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical
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December 8, 2022
5 FDA Warning Letters: Food Manufacturers of CBD Food Products
Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
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November 30, 2022
FDA UDI Labeling Requirements for FDA Class 1 Medical Device in 2023
Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand
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November 16, 2022
CFIA Enforcement of Nutrition Facts Table & CFIA Labeling Requirements
The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
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November 9, 2022
FSVP Compliance: Regulatory Assessment Record Keeping 2023
U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
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November 7, 2022
Food Labelling & Health Canada Packaging Update for 2023
Health Canada Announcement: The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and
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November 3, 2022
Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023
The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
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November 1, 2022
Health Canada’s Regulatory Enrollment Process (REP): Top 4 things to know
Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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September 9, 2022
Regulatory & Market Landscapes of CBD as a NHP
https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG)
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August 5, 2022
FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products
Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to
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August 4, 2022
Supplemented Foods: Food & Drug Regulations Unlocked in 2023
Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food?
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July 26, 2022
Regulations amending the Natural Health Products Regulations (NHPR) | What you should know!
What are the latest Natural Health Product Amendments (NHPR) Health Canada will be amending the Natural Health Products Regulations (NHPR)
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July 11, 2022
Nutrition Symbol Front-of-Food-Package Label Regulations
Health Canada recently announced that Front-of-package labelling changes for foods are set to come into effect on July 20, 2022,
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July 5, 2022
Prescription Drugs: Interim Implementation of Electronic Labelling
Background On April 22, 2022, Health Canada issued a notice to the industry on the interim implementation of electronic
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June 8, 2022
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July 14, 2025