Originally published in Healthcare Michigan, Volume 41, No. 4 The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics. Although these various product categories may appear to be clearly cut, the fact of the matter is that a product can very easily cross …
Keep the End in Sight: Expiration of the COVID-19 Declared Emergencies
Originally published in Healthcare Michigan, Volume 40, No. 3 As the year 2020 began, it would have been difficult for most Americans to imagine how life, as we knew it at that time, would change in the coming months and years. You likely recall generally, if not specifically, that on January 31, 2020, the Secretary of …
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Wait, Wait…Don’t Sell Me! FDA and Other Pre-Market Considerations for Commercial Products
The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products, cosmetics, food, including animal food, and electronic products that emit radiation. Canada’s equivalent is Health Canada (HC) and focuses on helping Canadians maintain …
FDA Authorization of COVID Vaccines – What Does it Mean?
One year ago, in March of 2020, the Secretary of the U.S. Department of Health and Human Services (Secretary) declared that, because of the public health emergency resulting from the number of confirmed cases of 2019 Novel Coronavirus (COVID), circumstances exist to justify the authorization by the Food and Drug Administration (FDA) of emergency use …
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Keeping Pace in Clinical Research: The Common Rule Picks Up Speed
In recent years, the world of human subjects research has expanded with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested and with respect to the technology employed to conduct the research and the nature of the research itself. For example, increasing reliance on repositories …
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