Alexa Sengupta

Alexa Sengupta

K&L Gates LLP

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FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation...more

10/12/2023  /  Clinical Trials , Documentation , Food and Drug Administration (FDA) , Informed Consent , Investigations , Life Sciences , New Guidance
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