US FDA identifies cybersecurity risks in certain patient monitors
The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with ...
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Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.