Choosing Between GRAS Notice and Self-Affirmed GRAS
Learn the key differences between GRAS Notice and Self-Affirmed GRAS to ensure FDA compliance and food safety. Find the best approach for your product.
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October 31, 2023
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[blog_list]
Health Canada’s Notice Enables the Use of L-alpha Glycerylphosphorylcholine in Supplemented Food
Health Canada Approves Alpha GPC in Foods On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC)
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September 21, 2023
Navigating Cosmetic Product Regulations through FDA Recent MoCRA Update
https://youtu.be/uuXA8yHrrZc Introduction: In response to the FDA’s recent draft guidance on the Registration and Listing of Cosmetic Product Facilities and Products,
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September 20, 2023
How to prepare and submit an eStar 510k Submission as of October 1st
Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023,
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September 15, 2023
AAFCO Membership Approves New Pet Food Regulations for Enhanced Transparency and Consistency
Introduction In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul
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August 24, 2023
New CFIA regulatory responsibilities regarding caffeinated energy drinks
The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety
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August 18, 2023
US Cosmetic Regulatory Requirements for Manufacturers (MoCRA Regulations)
https://youtu.be/uuXA8yHrrZc Introduction: Behold the “Modernization of Cosmetic Regulation Act of 2022” that President Biden signed on December 29, 2022. This
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August 9, 2023
Everything you should know about the registration and listing of Cosmetic Product Facilities and Products
This guidance provides suggestions and instructions to assist in submitting cosmetic product facility registrations and product listings to the FDA.
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August 8, 2023
NHPs considered a therapeutic drug product under Vanessa’s Law
Introduction: Health Canada’s new dietary supplement regulations, which are intended to revamp an already successful system, are unintentionally harming both
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July 17, 2023
FDA Toxicological Testing guidance for food additives Clinical Trials
The safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post
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June 21, 2023
FDA guidance for EUA medical devices transition under PHE policies
The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
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June 13, 2023
Health Canada interim policy extension on importing and selling infant formula
Introduction: By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products
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May 18, 2023
NNHPD Improvements to support NHP site licensing
What improvements are being made to support NHP site licensing? Internal template updates support: consistency between reviews-Fall 2023 Increased efficiencies
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May 12, 2023
FTC puts nearly 700 companies on notice of product claim civil penalties
Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
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April 21, 2023
FDA to close VCRP to prepare for MOCRA registration in 2023
Introduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to
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April 4, 2023
FDA Registration Renewals: FDA Increases Facility Enforcement
As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
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March 22, 2023
Health Canada Medical Device License Renewals (MDL or MDEL) in 2023
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
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March 22, 2023
FDA Fees for Medical Device Establishment Registration in 2023
The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023
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March 16, 2023
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.
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March 7, 2023
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,
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March 7, 2023
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July 14, 2025