2023 Hospital Manufacturing Patient-Centered 
FDA Law Blog
MAY 30, 2024
Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.
FDA Law Blog
JULY 17, 2022
An example of such a drug is a single-use vial of an injectable cancer drug that is dosed based upon weight, and therefore might not be entirely used for a lighter weight patient. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.
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FDA Law Blog
JANUARY 5, 2023
To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.
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. Im b leary eyed.
FDA Law Blog
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.
FDA Law Blog
MAY 21, 2024
29, 2023) (“Basis”); NPRM at 44,603. Scientific Evidence of Marijuana’s Pharmacological Effects, If Known HHS found that marijuana abuse can lead to negative consequences that include addiction and the need for medical attention through poison center calls or emergency room visits. Basis at 18; NPRM at 44,605.
GeriPal
OCTOBER 31, 2024
And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath. But it feels the same in that I was on call a lot over the summer, and I took care of a lot of people behind those hospital walls. I want to hear Kelly Clarkson, and I want to hear her sing.
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