Bill of Health

AUGUST 29, 2022

If one of the goals of the foster care and juvenile justice system is to prepare youth to live independently, make informed decisions, and navigate the world, then the interests of society are best served by involving and praising the voices of youth in these decisions. Victoria Kalumbi received her JD from Harvard Law School in 2022.

COVID-19 Vaccine 130

COVID-19 Vaccine COVID-19 Informed Consent Governance 130

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

Healthcare Law Blog

AUGUST 9, 2023

The now-active provisions include a prohibition on abortions after 12 weeks of pregnancy (with limited exceptions), 72-hour informed consent requirements, pre-abortion gestational age verification, and reporting requirements for abortions after 12 weeks. [21] United States FDA , 2023 U.S. for Hippocratic Med. 7, 2023). [2]

Licensing 52

Licensing Informed Consent Nurses FDA 52

Kaiser Health News

NOVEMBER 27, 2023

Transgender Care Florida Under DeSantis, Florida passed a law this year banning gender-affirming health care for trans minors and mandating that adult patients sign informed consent forms before starting or continuing hormone treatment.

COVID-19 Vaccine 117

COVID-19 Vaccine COVID-19 Medicaid Medicaid 117

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

FDA 105

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

Drug & Device Law

DECEMBER 21, 2023

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. The FDA, for one, advised patients to keep using these drugs.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

APRIL 21, 2023

Heck, Bexis and our colleague Matthew Jacobson even wrote a law review article on the topic a few years back. The FDA regulates medical devices, including 3d-printed medical devices when made by medical device manufacturers (see here for more information). There is no intermediary!

Informed Consent 59

Informed Consent Malpractice FDA Regulatory Compliance 59

Drug & Device Law

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). The article stated that each of the thirty-three individuals had no known asbestos exposure other than talcum powder. That article has “junk science” red flags flying all over it. So Dr. Moline set out to fill that void.

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Such power rests solely with the FDA.” Of course, when one sees this kind of ridiculous no-injury claim, one knows a class action is involved – why we’ve repeatedly advocated the abolition of Fed.

Doctors 52

Doctors Fraud Licensing Compliance 52