Cosmetic Labelling Rules Every Business Should Understand
Introduction: Cosmetic labelling is an essential part of developing and marketing cosmetics. Companies must meet government requirements for labelling, including ingredient listings, cautions and warnings, cosmetic claims, directions for use and other information needed for safety and consumer understanding. This guide outlines the necessary requirements of cosmetic labelling in Canada. Understanding Cosmetic Labelling Regulations and
... Read moreFDA Draft Guidance Labeling Plant Based Milk Alternatives in 2023
Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of plant-based products marketed and sold as alternatives to milk (plant-based milk alternatives, or PBMA). This draft guidance will provide industry with recommendations that will result in clear labelling, allowing consumers to make more informed purchasing
... Read moreHealth Canada Latest Draft Guidance (Biologic Regulations, Drug Labelling, NDS/ANDS & Drug Submissions Rolling Reviews)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 essential information about the regulations, legal requirements, and specific steps involved in the submission process for new drugs in Canada. Health Canada has been busy lately releasing several draft guidance documents related to drug compliance
... Read moreFiling a Medical Device 510(k): Timing and Process Explained
Introduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market a new device that is substantially equivalent to a legally market device. Submitting a 510k to the FDA is an important step for any business or healthcare product that needs to be approved for sale.
... Read more5 Tips to find the best FDA Medical Device Regulatory Consultant
Introduction: Navigating the intricate web of medical device regulations can be daunting for businesses unfamiliar with the regulatory landscape. Hiring a professional medical device regulatory consultant can provide the expertise and knowledge necessary to ensure compliance with both federal and international laws. Selecting the ideal FDA medical device regulatory consultant is crucial, particularly given
... Read moreHow to Achieve GRAS Status for Your Ingredient
Learn the FDA process to achieve GRAS status for your ingredient and ensure it meets safety and compliance requirements.
... Read moreWhat Businesses Need to Know About FDA NAC Guidelines
We explore the FDA safety guidelines for NAC Supplements including marketing/labeling and utilizing FDA resources for guidance.
... Read moreHow to Navigate Regulatory Requirements for Class III Medical Devices
Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements. Class 3 medical devices are especially complex and pose the highest risk to
... Read moreWhat Does It Mean to be GFSI Certified in an FSMA Environment?
Introduction: FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government to ensure food safety and decrease the risk of foodborne illness. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including
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