FDA Law
NOVEMBER 14, 2022
The facility fee applies to a single manufacturing facility. The guidance explains that a facility counts as a single facility subject to a single facility fee if it is under one management and in one geographic location and address, and is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug product.
The Clinical Problem Solvers
NOVEMBER 6, 2023
Siddiqui October 31, 2023 Summary : This episode highlights the culture of food shaming and anti-fatness as it relates to anti-Blackness. Harrison, a community organizer and trans theorist, and Dr. Psyche A. During this episode, we hear from Da’Shaun L. Williams-Forson, Da’Shaun L. All of this contributes uniquely to social death.
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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. Because we don’t.
Common Sense Family Doctor
FEBRUARY 15, 2025
On Sensible Medicine, Dr. Edward Livingston pointed out that the manufacturer, AbbVie, spent $580 million on DTCA for this drug in 2023, or $290 for each of the 2 million potential patients in the United States. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns.
FDA Law
OCTOBER 17, 2023
This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.
FDA Law
MAY 21, 2024
29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. Memorandum for DEA, from HHS, Re: Basis for the Recommendation to Reschedule Marijuana to Schedule III of the Controlled Substances Act, at 9 (Aug.
FDA Law
DECEMBER 14, 2023
The governors (of Colorado, Illinois, Louisiana, Maryland, New Jersey and New York) thanked the President for his leadership in directing the Department of Health and Human Services (“HHS”) to reconsider the current scheduling of cannabis and HHS’ August 2023 rescheduling recommendation to the Drug Enforcement Administration (“DEA”).
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