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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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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Hall Render

SEPTEMBER 14, 2023

Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.

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Healthcare IT Today

AUGUST 9, 2022

The following is a guest article by Natalie C. The use of AI is revolutionizing the delivery of healthcare, but its use comes with significant ethical challenges that cannot be ignored, the most important of which involve bias and informed consent. . Oehlers, Associate Attorney and Carly C. Overall Recommendations .

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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 application/notification must be submitted via the EUDAMED database (Article 69 IVDR).

US Department of Health and Human Services 40

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

SQA

MAY 17, 2022

China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 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).

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Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. has no power to enforce compliance”), aff’d , 405 F.

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Doctors Fraud Licensing Compliance 52

Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. Instead, Zofran turned mainly on animal studies – three Japanese studies that were not “newly acquired information” that could avoid preemption. 4th 315 (6th Cir. Bonta , 85 F.4th

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