Bill of Health

JULY 14, 2023

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S In 2017, Congress acted again to update the Common Rule and strengthen the provisions related to consent. While the U.S. These warnings echo those of the U.S.

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Informed Consent FDA Public Health World Health 130

Bill of Health

FEBRUARY 26, 2024

Much has been made of recently discussed CAR-T cell therapies for cancer , which have been around since 2017, and in-human sickle cell treatment Casgevy. In December 2022, the FDA Modernization Act 2.0 Would they classify as a medical device or biologic under FDA guidelines, or perhaps as a combination product?

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FDA Informed Consent Bioethics 113

Health Populi

MAY 30, 2018

This is important because in 2017, one in four new drugs approved by the FDA were designed to treat a small population, falling. The team analyzed data-sharing guidelines across 230 policy documents published between 1996 and 2017. into the precision medicine category. Note that autonomy and privacy rank with the most mentions.

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Informed Consent FDA Health Insurance HIPAA 69

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. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

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

Bill of Health

AUGUST 29, 2022

7] E.g. , Fanaroff, Consent by Proxy for Nonurgent Medical Care , 139 Pediatrics e1, e2 (2017); see also Minors’ Consent Laws | Law | Policy and Law | HIV/AIDS | CDC, [link] (last visited Jan 16, 2021) (indicating that 46 states have an age of majority of 18; only Alabama, Mississippi, Nebraska, and Pennsylvania have a higher age of majority). [8]

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

DECEMBER 21, 2023

255 (2017) ( 2017+1 ). FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. But here we are. 3d 18 (Cal.

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FDA Fraud Informed Consent 52