Articles and Blogs

Food & Drug Administration

A Year Later—Revisiting FTC’s Updated Endorsement Guides

[07/17/24]

Posted on July 17, 2024 in Health Law News

Published by: Hall Render

It has been a year since the Federal Trade Commission (“FTC”) revised its Guides Concerning the Use of Endorsements and Testimonials in Advertising (“Endorsement Guides” or “Guides”), which advises businesses, influencers, brand ambassadors and other endorsers on how to ensure that advertising using reviews or endorsements is truthful. The FTC’s Endorsement Guides, found in... READ MORE

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FDA Outlines Considerations for Conducting Clinical Investigations Using Psychedelic Drugs

[09/15/23]

Posted on September 15, 2023 in Health Law News

Published by: Hall Render

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. The Draft Guidance is aimed at researchers conducting clinical trials using psychedelic drugs. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to... READ MORE

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FDA Details Authorized Treatment Pathways and Collection Requirements for Administration of COVID-19 Convalescent Plasma

[04/21/20]

Posted on April 21, 2020 in Health Law News

Published by: Hall Render

As the number of infections from severe acute respiratory syndrome coronavirus 2 (“SARS‑CoV‑2”), the virus that causes COVID-19, continues to rise globally, interest in effective treatment options remains a concerted focus internationally. One potential treatment option that holds promise is the use of convalescent plasma. The FDA’s recently released “Investigational COVID-19 Convalescent Plasma, Guidance... READ MORE

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FDA Revisits Unsubstantiated Claims Surrounding Pharmacogenetic Testing

[02/26/20]

Posted on February 26, 2020 in Health Law News

Published by: Hall Render

Pharmacogenetic Testing and the FDA’s 2018 Warning The advent of direct-to-consumer genetic testing has yielded an explosion in the development of various types of genetic tests for clinical treatment and diagnostic purposes. These tests include pharmacogenetic tests, which are used to better understand the role genetics play in an individual patient’s reaction to certain... READ MORE

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Novel Coronavirus 2019-nCoV and FDA’s Emergency Use Authorization Authority

[02/26/20]

Posted on February 26, 2020 in Health Law News

Published by: Hall Render

It is no secret why the novel coronavirus (“2019-nCoV”) outbreak in Wuhan City, Hubei Province, China quickly raised health concerns on an international scale. The coronavirus family contains member viruses with a similarly sinister and deadly past; viruses that seemingly appeared out of nowhere and rapidly spread. For example, two betacoronaviruses were the culprits... READ MORE

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What’s in YOUR Cannabidiol Product Claim? FDA and FTC Want to Know

[10/24/19]

Posted on October 24, 2019 in Health Law News

Published by: Hall Render

It isn’t only the U.S. Food & Drug Administration (“FDA”) and Drug Enforcement Agency (“DEA”) that are interested in all things cannabis. Today, the FDA followed earlier warning letters[1] by posting yet another press release regarding an October 10, 2019 warning letter that was issued jointly by the FDA and the Federal Trade Commission... READ MORE

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