GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. We begin with a refresher on psilocybinwhat it is, how it might work, what conditions it may help treat (including demoralization), and how its typically administered. It’s there.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. 21 U.S.C. §

Medical 69

Medical Physicals IT Healthcare Professional 69

FDA Law

MAY 5, 2024

Letter to DEA Administrator Anne Milgram, from Assistant Secretary for Health Rachel Levine (Aug. 29, 2023). By recommending rescheduling to schedule III, FDA/HHS determined that marijuana no longer meets schedule I criteria under the CSA and that it does not meet schedule II criteria either. Letter to U.S. 21 U.S.C. § 812(b)(1).

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

FDA Law

AUGUST 21, 2023

It’s important to note here that the warnings and precautions listed in the acetaminophen labeling complied with FDA’s Pregnancy Rule (which applies to all OTC systemic products), stating “if pregnant or breast-feeding ask a health professional before use,” and with the acetaminophen OTC Monograph and the relevant NDAs.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

Healthcare 129

Healthcare IT Education Community 129

FDA Law

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. § NPRM at 44,619. NPRM at 44,601. Basis at 37; NPRM at 44,610.

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

OCTOBER 31, 2024

Alex 00:07 We are delighted to welcome back Lona Mody, who is a geriatrician, translational infectious disease researcher, and professor at the University of Michigan and the Ann Arbor Va. Lona, welcome back to GeriPal. Lona 00:21 It’s great to be here. Peter, welcome to the GeriPal Podcast. Peter 00:36 A pleasure to be on Alex and Eric.

Vaccination 127

Vaccination IT Patient-Centered Patients 127

FDA Law

JUNE 1, 2025

The bill would also mandate that drug manufacturers report payments to influencers to the federal Open Payments database, similar to current requirements for physicians. This year is shaping up a bit differently with all four OPDP enforcement letters addressing healthcare professional materials (including a speaker slide deck!!).

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59