Jessa Boubker

Foley & Lardner LLP

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Latest Posts › Coronavirus/COVID-19

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FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more

5/8/2023 / Biologics , Clinical Trials , Coronavirus/COVID-19 , Draft Guidance , Food and Drug Administration (FDA) , Investigations , Pharmaceutical Industry , Prescription Drugs , Privacy Laws , Reimbursements

FDA Drafts Public Health Emergency Transition Plan: What Device Manufacturers Need to Know

The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key...more

1/7/2022 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Public Health Emergency

3D Printing Medical Devices at the Point of Care — FDA Invites Feedback

The U.S. Food & Drug Administration (FDA) recently issued a discussion paper to gather feedback that will inform future policies and guidance regarding 3D printing medical devices at the point of care. Amidst COVID-19...more

12/17/2021 / 3D Printing , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Regulatory Requirements , Supply Chain , Supply Shortages

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