Alexa Sengupta

Alexa Sengupta

K&L Gates LLP

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Latest Posts › Food and Drug Administration (FDA)

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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

Litigation Minute: FDA and State Action on PFAS in Food Packaging (PFAS Series: Part One)

Known for being resistant to grease, oil, water, and heat, per- and polyfluoroalkyl substances (PFAS) have had a number of applications in food-contact materials regulated by the US Food and Drug Administration (FDA)....more

6/30/2023  /  Food and Drug Administration (FDA) , Food Contamination , Food Safety , Food Supply , PFAS
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