article thumbnail

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation

Bill of Health

He is a psychiatric mental health nurse practitioner, co-founder of the Psychedelic Society of Western New York, and led the development of a grassroots psychedelic harm reduction organization called the Sanctuary Project. Kwasi Adusei , D.N.P.

FDA 144
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s). United States Food and Drug Administration (FDA) – Regulations and Guidances.

FDA 75
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Health Care Is Front and Center as DeSantis and Newsom Go Mano a Mano

Kaiser Health News

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.

article thumbnail

Health Provider News – February 10, 2023

Hall Render

Dunleavy proposes extending Medicaid coverage for new mothers ARIZONA Banner Health pays $1.25M penalty over HIPAA failures from 2016 breach Arizona nursing school at risk of losing accreditation St. billion since pandemic U.S. billion since pandemic U.S. Blue Shield of California is counting on it.

article thumbnail

Part 3: An Update on the Federal and State E-Roe-sion or P-Roe-tection of Abortion Rights

Healthcare Law Blog

State of Montana , the Montana Supreme Court upheld a lower court decision that blocked a law preventing advanced practice registered nurses from providing abortion care. [20] United States FDA , 2023 U.S. 20] North Carolina : Several provisions of S.B. 21] Beginning on October 1, 2023, more provisions of S.B. for Hippocratic Med.

article thumbnail

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

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