Lexology May 5, 2023
On May 2, 2023, FDA issued a draft guidance document providing insights into the Agency’s approach to regulating decentralized clinical trials (“DCTs”) for drugs, biological products, and devices (“DCT Draft Guidance”). The DCT Draft Guidance builds on Agency recommendations issued beginning in March 2020 to facilitate trial decentralization in response to the COVID-19 pandemic and associated clinical trial disruptions such as quarantines, site closures, and travel limitations. As part of the Food and Drug Omnibus Reform Act (“FDORA”), enacted in late 2022, FDA was required to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices”—a requirement that is addressed by the DCT Draft...
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