Bill of Health

APRIL 7, 2022

(he/him or they/them) has been personally utilizing psychedelics and other substances in celebratory and spiritual contexts for over fifteen years, and has been actively participating in the drug policy reform movement since 2013. Justin is currently engaged in clinical work seeking to expand the reach of harm reduction services in New Haven.

FDA 147

FDA Nurses Informed Consent Public Health 147

SQA

MAY 17, 2022

ANVISA’s RDC 665/2022 (link in Portuguese) replaces previous regulations, including RDC 16/2013 and IN 08/2013, and went into effect on 02 May 2022. United States Food and Drug Administration (FDA) – Regulations and Guidances. Additional details for each annex are provided within the content section of the document.

FDA 75

FDA Compliance Informed Consent Hospitals 75

Bill of Health

AUGUST 29, 2022

439, 448 (2013). [15] Sugarman, 566 F.2d 2d 817, 825 (2d Cir. 13] San Antonio Indep. Rodriguez, 411 U.S. 1, 35 (1973). [14] 14] Erin C. Fuse Brown, Developing a Durable Right to Health Care , 14 Minn. & Tech. 15] Emily Parker, Constitutional Obligations for Public Education , Educ.

COVID-19 Vaccine 130

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.

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

2013) (Painter); McClellan v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II) , 341 F. 3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co. ,

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

JUNE 6, 2022

2013 WL 4516160, at *3 (N.M. 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. . . 2013 WL 85291, at *8 (D.N.J. 2013 WL 1758647, at *5 (D.N.J. 3d 704 (5th Cir.

FDA 59

FDA Doctors Malpractice Informed Consent 59