You have probably heard of the terms IND and NDA being used during drug development and applications. People tend to get confused between the two terms and wonder how they […] Read More >>
In regulatory affairs, a dossier is a term used to describe a compilation and array of documents regarding the safety, efficacy, and quality information of a medical product. The dossier […] Read More >>
During the pandemic of respiratory disease caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or Coronavirus Disease 2019 (COVID-19), the FDA Commissioner may authorize the use […] Read More >>
COVID-19 tests are considered medical devices and are regulated under the Medical Devices Regulations in Canada. Medical devices are classified into 4 classes: Class I are those with the lowest […] Read More >>
In 2000, a group of professionals from the food industry gathered with the goal of collaborating and finding solutions for the food industry challenges, most notably to reduce food safety […] Read More >>
Regardless of whether you are developing a new food or dietary supplement/natural health product (NHP) that you intend to sell in either the United States, or Canada, you must follow […] Read More >>
Clinical research in Canada has seen a significant uptick in interest from Sponsors and Investigators since the onset of the COVID-19 pandemic. This interest is perhaps a precipitate of increasing […] Read More >>
Health Canada has recently notified the industry that TMAL (Temporary Marketing Authorization Letter) holders for supplemented foods (and caffeinated energy drinks) which are set to expire on December 31, 2021, […] Read More >>
If you are currently using a COVID-19 Site Licence to manufacture, package, label, or import alcohol-based hand sanitizers, your licence will expire September 30, 2021. Background In August of 2020, […] Read More >>
On July 16, 2021, Health Canada issued a Notice to Interested Parties about a Proposal to amend the Cosmetic Regulations.According to the notice, the Proposal is open to pre-consultation from […] Read More >>
A clinical trial protocol is a document that is designed to outline all details of a clinical trial. It is the main document referred to throughout the trial lifecycle and […] Read More >>
In May of 2021, Health Canada announced a proposal to modernize the regulatory framework for Clinical Trials. This proposal hopes to help improve support the introduction of novel safe and […] Read More >>
Within a business, the organizational work culture integrates larger groups of people, not individuals alone, and this reflects on how these groups interact and behave. Food businesses are no different, […] Read More >>
N-acetyl-L-cysteine (NAC) is an amino acid that was approved by the FDA as a drug in 1963. Its primary uses as a drug include relieving symptoms of respiratory ailments as […] Read More >>
According to a keynote speech during New Hope Network’s Spark Brand Success event in March of 2021, organic food and beverage sales in the United States rose 13% to $186 […] Read More >>
Amazon has made changes on Seller Central, this time to their policies for medical gloves sold on their marketplace. Sellers on Amazon are being alerted to new forms of documentation […] Read More >>
Back in the 1960s a revolutionary breakthrough in x-ray technology lead to the invention of the dual-energy x-ray absorptiometry (DXA) machine. This new technology, introduced by Dr. Richard Cameron and […] Read More >>
Important update for anyone who manufactures, packages, labels, or imports sesame or products that contain or may contain (come into contact with) sesame into the United States. On April 23, […] Read More >>
Just months after announcing that new documentation would be required for supplements sold on their marketplace, Amazon has again updated their requirements, this time without an announcement. In this latest […] Read More >>
Are you concerned that the dietary products that you consume are safe and that the environment in which they are manufactured is up to a particular standard? Well, you should […] Read More >>
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