On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health. The dietary […] Read More >>
The FDA recently published responses to several new dietary ingredient notifications (NDIN) submitted for nicotinamide mononucleotide (most notably the November 8, 2022 response to Inner Mongolia Kingdomway Pharmaceutical Ltd. “Kingdomway”). […] Read More >>
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. Usually endemic to regions of central and […] Read More >>
Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids. Bioanalytical testing involves using a validated bioanalytical method for the […] 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 >>
As innovation continues to evolve in digital health technologies, Health Canada is undertaking an adaptive initiative to support better access to those therapeutic products, especially in relation to medical devices. […] Read More >>
Digital Health covers a broad scope of categories in mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Digital health tools range from mobile medical […] Read More >>
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 >>
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 >>
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 >>
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 >>
The dates for renewal are now open. The Food and Drug Administration (FDA) requires that all businesses that manufacture, process, pack, or store food, beverages, or dietary supplements for sale […] Read More >>
In the US, drugs may either be prescription drugs, requiring a prescription by an authorized health care provider, or they may be over-the-counter (OTC) drugs, which are purchased directly by […] 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 >>
As the regulatory landscape continues to evolve for the nascent CBD-hemp industry in the USA, many have questioned whether cannabidiol (CBD) the non-psychoactive component naturally occurring in hemp is generally […] Read More >>
On November 5, 2018, the Federal Register revealed new guidance on Nutrition and Supplement Facts Labels with questions and answers related to the Compliance Date, Added Sugars, and Declaration of […] Read More >>
In July of this year, the FDA announced new innovative approaches that demonstrate safety and efficacy for nonprescription drug products while expanding consumer access to more products. These innovative approaches […] Read More >>
ISO Prepares for FDA’s Proposed Overhaul of Medical Device Quality System Regulation Late in February 2018, the FDA announced that as part of global harmonization efforts around quality management systems, […] Read More >>
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