FDA Law Blog: Biosimilars
FEBRUARY 11, 2025
Houck One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees.
PharmExec
DECEMBER 20, 2024
In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, discusses the recent DEA extensions of telehealth for controlled substances and new treatment modalities or patient populations he anticipates will become more accessible through telehealth in 2025.
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FDA Law Blog: Biosimilars
DECEMBER 12, 2024
The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. Last weeks prehearing conference set the parameters for the hearing on the merits, scheduled to begin January 21, 2025. Prehearing Ruling (Dec. 4, 2024), at 1.
pharmaphorum
DECEMBER 14, 2022
Harmony Biosciences introduced Wakix to the market in 2019 as the first non-controlled substance for the treatment of narcolepsy. For Avadel’s Lumryz, the one-dose extended-release oral suspension that allows narcolepsy patients to sleep through the night, the worst-case scenario is it won’t be on the market until 2025.
FDA Law Blog: Biosimilars
FEBRUARY 18, 2025
23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlled substances to patients without resolving numerous red flags of diversion. In Neumanns Pharmacy, LLC , 90 Fed.
FDA Law Blog: Biosimilars
NOVEMBER 21, 2024
temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. use of buprenorphine) for opioid use disorder, and for Schedule III-V non-narcotic controlled substances unless the patient receives an in-person examination.
FDA Law Blog: Biosimilars
MARCH 6, 2025
This statement followed a February 20, 2025 letter from Acting Solicitor General Sarah Harris to President Pro Tempore of the Senate Charles Grassley stating the same and noting that the Department will no longer defend the layers of removal restrictions for ALJs in court. Bondi , No. 3:23-cv-2883-E, ECF No.
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