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Food & Drug Administration

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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