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FDA Law
MAY 5, 2024
29, 2023). FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. Letter to DEA Administrator Anne Milgram, from Assistant Secretary for Health Rachel Levine (Aug. Letter to U.S. Letter to President Joseph R. 21 U.S.C. §
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. By Larry K. HHS forwards FDA’s analysis and recommendation to DEA.
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GeriPal
MAY 8, 2025
Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.
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.
FDA Law
MAY 21, 2024
29, 2023) (“Basis”); NPRM at 44,603. 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.
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.
FDA Law
JUNE 1, 2025
Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value. Its unclear whether there are truly regulatory gaps that require new legislation.
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