Health Care Law News and Insights

Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue. Companies interested in providing clinical trial services via telehealth have to deal with whether the carrying out the clinical aspects of a clinical trial...

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In a report entitled "Bold Goals for U.S. Biotechnology and Biomanufacturing," the White House recently announced several biotech-related "bold goals" to advance the environmental, agricultural, economic, health, and science fields. The publication follows President Biden's Sept. 12, 2022 Executive Order on "Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure...

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Clinical trial diversity is not a new concept–the U.S. Food and Drug Administration (FDA) issued a draft guidance providing specific recommendations to industry on how to improve diversity in clinical trials in April 2022 which we blogged about here–but the passage of the Food and Drug Omnibus Reform Act, or FDORA, highlighted that...

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