Bill of Health

JANUARY 29, 2024

In 2013, for instance, I published an essay titled “ A Declaration of Psychedelic Studies ,” which began with these words: “The scientific research community is in the midst of a ‘psychedelic renaissance,’ but sanctioned platforms for mainstream discussion are heavily weighted in the direction of objective scientific research.

Informed Consent 355

Informed Consent Bioethics Doctors 355

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.

FDA 144

FDA Nurses Informed Consent Public Health 144

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. ANVISA has issued a new resolution that updates Brazilian Good Manufacturing Practices (BGMP) for medical devices and in vitro diagnostic (IVD) products.

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 21, 2023

Bexis’ amicus efforts this year in Mallory obviously came to naught, and we’ve had our own cases on this list before (see, e.g. , 2013-2 and 2021-10 ). If you’ve been burned by any of these judicial debacles, we sympathize. A lawyer who never loses doesn’t litigate hard cases. The penalty did not hold up, but the duty did.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

MAY 25, 2023

Another motion reflected Bexis original position (but wasn’t Bexis’ motion), that the Institute should prepare black letter, comments and reporters’ notes for both sides of this issue, similarly to the manner in which the same draft handled the question of patient-oriented versus physician-oriented standards for informed consent.

Informed Consent 59

Informed Consent Malpractice Governance 59

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. The G/N MDL was created in 2013 and mostly settled in 2016. In Cates the plaintiff encountered an unusual – so unusual as to be called “paradoxical” − but known, adverse reaction. The device labeling specifically mentioned it. 13) McGee v.

FDA 105

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