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FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App
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More Healthcare & Pharmaceuticals | Government & Public Sector | Life Sciences Aricles → Latest Firm's PressVerrill On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” with new information on the use of electronic signatures on clinical trial records and a reference to FDA’s COVID MyStudies App as an option for obtaining electronic informed consent. This follows a prior update released by FDA on May 14, 2020, also described below. To learn more about FDA’s guidance in this area, please see our prior alerts on our COVID-19 resource center for health care and life sciences clients here. FDA’s update of June 3, 2020 added guidance addressing:
FDA’s update of May 14, 2020 added guidance addressing:
For questions, please contact Sarah V. Ferranti, Andrew P. Rusczek, or your regular Verrill attorney.
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