Pharmaceutical drugs go through a rigorous process that tests their safety and efficacy before gaining FDA approval and being put on the commercial market. Traditionally, preclinical trials utilize mammalian models before clinical trials are performed (mammals are considered the gold standard of trials). But are these trials serving everyone? This article will discuss the pervasive inequality between the male and female sexes in drug development and what can be done about it.
In this article we will explore how the nutraceutical regulations compare in the USA and abroad, asking how they are defined in each country, what licensing is needed, how this affects manufacturers, and what this indicates for the future of the market.
Thanks to InVivo Biosystems, Dr. Galyan now has the data necessary to present to investors to fund additional research into the compound. Additionally, he was able to use the data to submit a patent application on the compound in September of 2021.
In this article we aim to clarify the intent behind these therapies and what their labelling means by asking: Why aren’t nutraceutical products FDA approved? How do FDA and FTC approvals compare? And — how should you market your product? What legal issues do both tracks pose?
The FDA’s emergency use authorization (EUA) of the COVID-19 vaccines has brought the approval process of vaccines and drugs into public consciousness, however, the FDA’s ability to streamline medical products is not new. In this article we will discuss the history of the drug development pipeline, and ways it can be improved.
Getting a drug to market is notoriously difficult, taking 7-10 years and costing hundreds of millions of dollars. This, coupled with the Covid-19 pandemic’s impact on clinical trials, may make you wonder whether your drug is eligible for an expedited track. In this article we will discuss the current ways of expediting drugs, and which is best for your research.
Rising healthcare costs mean it’s time for pharmaceutical companies to use non-mammalian models in their drug development process — by saving time and money pharmaceutical companies can make a return on their products without sky-high prices for consumers.
Using Humanization we can take advantage of the ancient biology between humans and other organisms to create stand-ins – patient avatars – for drug screening studies. In this blog, we will focus on models of inborn errors of metabolism (IEM), as these genetic conditions can lead to hypersensitivity to the metabolite. Since stressor condition hypersensitivity can be used to detect favorable drug effects, IEM model systems are ideal tools for phenotypic screens to find molecules that alleviate the metabolic stress occurring from the deficiency. We discuss the model organisms used in hypersensitivity screens, and why they are advantageous to drug discovery. Ultimately, showcasing this approach’s potential to be widely generalized to many genetic disorders.