HIT Consultant

NOVEMBER 17, 2021

Recent statements by the FDA and EMA support this emphasis, calling out the need for education and training of all constituents in a clinical trial to reduce unwanted protocol deviations and improve overall quality in clinical trial operations. and led client services and product expansion at OneHealth.

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COVID-19 Pharmaceutical Industry Informed Consent Compliance 97

SQA

FEBRUARY 15, 2023

Where electronic certificates produced and issued by the provincial application system are used, the provincial drug regulatory department shall clarify the relevant guidelines to enterprises within its administrative region and provide guidance and services. ” The requirements for providers (e.g.,

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

Postal Service permanent authorization to continue mailing abortion pills, including to states where abortion is severely restricted. United States FDA , 2023 U.S. Supreme Court blocked Judge Kacsmaryk’s ruling to preserve nationwide access to the drug, as explained in further detail in our Mifepristone post. 5 into law. 7, 2023). [2]

Licensing 52

Licensing Informed Consent Nurses FDA 52

Bill of Health

AUGUST 29, 2022

They are at the mercy of authority figures from multiple systems—the judiciary, government officials who oversee their day-to-day health, safety, and wellbeing, parents or legal guardians who may retain control over their bodily autonomy and decision making, and service providers who have access into the story of their lives.

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Hall Render

FEBRUARY 10, 2023

s Unity Health Care expanding services, adding staff in push for health equity A look back on the 2022 CRE themes in the health care industry in the D.C. billion since pandemic U.S. billion since pandemic U.S. Blue Shield of California is counting on it.

US Department of Health and Human Services 40

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

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. Nearly 26,000 people are homeless in Florida, or 12 of every 10,000 residents.

COVID-19 Vaccine 107

COVID-19 Vaccine COVID-19 Medicaid Medicaid 107

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.

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FDA Fraud Informed Consent 52

Drug & Device Law

AUGUST 8, 2022

A myriad of other industry, medical, and online organizations certify and rate an almost endless variety of goods and services. Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. Such power rests solely with the FDA.” Heck, even lawyers get rated.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

DECEMBER 29, 2023

United States Department of Health and Human Services , 58 F.4th 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. 4th 851 (6th Cir.

FDA 105

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

Drug & Device Law

APRIL 21, 2023

Courts have long seen healthcare providers as service providers to whom product liability law does not apply. 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

FEBRUARY 26, 2024

As much as we like preemption, no basis for preemption exists based with respect to the informed consent requirement of the statute’s provision governing emergency use authorized (“EUA”) products, such as (at the time) COVID-19 vaccines. Second, the FDCA (21 U.S.C. CHDI , 2024 WL 637353, at *5. Cuomo , 592 U.S. 14, 18 (2020)).

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COVID-19 COVID-19 Vaccine Informed Consent FDA 52

Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. Providence Health & Services , No.

COVID-19 59

COVID-19 Informed Consent FDA Governance 59

Drug & Device Law

MARCH 9, 2022

Speaking of clothing, sometimes plaintiff regulatory experts engage in cosplay, donning a quasi-military uniform from their service in the FDA many decades ago. This masquerade occurs despite the fact that the expert’s prior FDA position had little or nothing to do with the subject of the litigation. No Informed Consent.

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Informed Consent FDA Doctors Licensing 64

Drug & Device Law

JUNE 14, 2023

Of course, on the defense side, we’re usually as happy as clams if we can show that the Food and Drug Administration (FDA) has already decided which warnings are necessary, so let’s call it a day. There is no carve-out for informed consent. And therein, in a strange way, lies our interest in Francisco v. 2023 WL 3589654 (Ariz.

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FDA Malpractice Informed Consent Doctors 59