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 >>
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 >>
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 >>
In vitro diagnostic medical devices contain a broad spectrum of devices that test biological samples to determine the status of one’s health, from self-tests for pregnancy, to blood glucose tests […] Read More >>
On July 15, 2020, the next scheduled compliance date for the Safe Food for Canadians Act & Regulations came into effect for businesses in the manufactured food sector. The compliance […] Read More >>
To facilitate the distribution of food during the COVID-19 pandemic, the US FDA recently issued a guidance document titled “Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health [&hell Read More >>
The Food and Drug Administration (FDA) recently published a new guidance document to help expand the availability of surgical apparel, including gowns, hoods, and surgical & patient examination gloves, in […] Read More >>
The COVID-19 pandemic has precipitated an unprecedented public health situation in the United States of America, disrupting supply chains and creating shortages of products aimed at preventing infection. As a […] Read More >>
With the recent announcement that Coronovirus has gone pandemic, consumers are flooding supermarkets, and preparing for indeterminate periods of self-isolation. All the while the marketplace is reeling, seeing demand for […] Read More >>
Based on what is currently known about the novel coronavirus (COVID-19) and similar coronaviruses that cause SARS (Sudden Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome), the most common […] Read More >>
STAY ALERT AND AWARE OF PENDING CHANGES THAT MAY IMPACT YOUR BUSINESS How does the Food Safety Modernization Act affect your business? What do the latest guidance documents say? What are […] Read More >>
November 8, 2013 Phase I of the NHP Compliance and Enforcement transition period is ending December 1, 2013. Companies have been advised to ensure that they are familiar with and […] Read More >>
March 26, 2013: dicentra conducted its first webinar of 2013. Critical American and Canadian updates including FDA’s proposed rules to amend cGMPs for food facilities under FSMA, the FDA’s Draft […] Read More >>
NHPD revises maximum daily limit of carvacrol for natural health products containing Oil of Oregano as a medicinal ingredient. Oil of oregano, derived from the species of Origanum spp., is […] Read More >>
Reprinted from Newhope 360 On Jan. 2, a new set of rules from Health Canada came into effect to limit allowable caffeine in food products. Single-serving beverages may now contain […] Read More >>
Topics covered: Canada: Consultations & Regulatory Initiatives Food Safety & Initiatives United States: Proposition 37 – Genetically Engineered Foods, Labeling, Initiative Statute Energy Drink Controversey Status of Draft NDI Guidance [&helli Read More >>
August 28, 2012 A Quick Note…. There have been a number of significant developments on the regulatory front for dietary supplements in the United States lately. For example, dietary supplement […] Read More >>
dicentra’s Regulatory Update Webinar – Q2 dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and […] Read More >>
May 10, 2012 Are You Making False Claims By Heather Van Blarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements If you don’t have “competent and reliable scientific evidence” […] Read More >>
http://www.nutraingredients.com/ June 16, 2011 EU ‘agreement’ may outlaw cholesterol labelling Optional cholesterol labelling of food products may soon be banned in the European Union if a draft regulation on food […] Read More >>