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 >>
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 >>
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 >>
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 Canada, prior to July 1, 2020, drugs, which are inclusive of prescription drugs, non-prescription drugs (also called over-the-counter [OTC] pharmaceuticals), and natural health products (NHPs), were not permitted to […] Read More >>
Put yourself in the shoes of the consumer for a minute…okay…ready? You walk into a health food store to purchase supplements that you recently learned about that you hope might […] 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 >>