SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

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. citizen or lawfully present in the country.

COVID-19 Vaccine 117

COVID-19 Vaccine COVID-19 Medicaid Medicaid 117

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.

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

NOVEMBER 28, 2022

While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). The “reason” was “to allow for public access to data that undermines claims that plaintiffs’ experts and counsel continue to present to courts and factfinders.” 11-17 (Jan. citation and quotation marks omitted). quoting 45 C.F.R.

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. Plaintiffs present no evidence that would suggest that if the [association’s expert committee] determines that an ingredient is unsafe for use, manufacturers must cease using that ingredient.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

JUNE 7, 2022

Plaintiff argued this conflicted with the learned intermediary rule because the FDA requires warnings to consumers when manufacturers market drugs to consumers. The FDA also requires warnings to physicians. Doctors are charged with discussing the risks and benefits of treatment and obtaining informed consent from their patients.

Doctors 69

Doctors FDA Informed Consent Malpractice 69

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. . . we’ll present the rest of these cases in state-by-state style: Alabama. Bayer HealthCare Pharmaceuticals, Inc. ,

FDA 59

FDA Doctors Malpractice Informed Consent 59