Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. On August 15, 2023, the U.S.

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Bill of Health

SEPTEMBER 23, 2022

Expanded Access is not intended to produce generalizable knowledge; however, it involves reporting of serious adverse events (SAEs) to the entity developing the product (the “sponsor”) and the regulatory agency (the U.S. Who qualifies for EA, and how does it work? Full committee review is appropriate.

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Healthcare Law Today

JANUARY 20, 2022

Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. The FDA, however, does not regulate all DHT products because the products do not always meet the definition of a medical device, e.g., a general wellness device.

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SQA

MAY 17, 2022

For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s). United States Food and Drug Administration (FDA) – Regulations and Guidances.

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SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. The MHRA has not received reports of adverse events involving Belzer UW MPS Machine Perfusion Solution.

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US Department of Health and Human Services FDA COVID-19 World Health 40

Hall Render

FEBRUARY 10, 2023

over Claims Practices Where things stand in Central California 1 month after a community hospital’s closure California hospital names Kelly Linden CEO Upcoming California health bills to watch, including a conversation with Rep. Blue Shield of California is counting on it.

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US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 8, 2019) (no causation where prescriber “testified that none of the additional risk information. . . 3d 812, 816 (11th Cir.

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