
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
... Read moreIntroduction: Health Canada’s new dietary supplement regulations, which are intended to revamp an already successful system, are unintentionally harming both
... Read moreThe safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post
... Read moreThe U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
... Read moreIntroduction: By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products
... Read moreWhat improvements are being made to support NHP site licensing? Internal template updates support: consistency between reviews-Fall 2023 Increased efficiencies
... Read moreIntroduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
... Read moreIntroduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to
... Read moreAs a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
... Read moreAs a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read moreThe cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023
... Read morePMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023.
... Read moreBackground: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose,
... Read moreIntroduction: The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following
... Read moreIntroduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of
... Read moreIntroduction: Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide
... Read moreIntroduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling
... Read moreIntroduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical
... Read moreIntroduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
... Read moreIntroduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand
... Read moreThe Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
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