FDA Law Blog: Biosimilars

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” By Larry K. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec. 50,372 at 50,372-73.

Controlled Substances 52

Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

MAY 21, 2024

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K. 44,597 (May 21, 2024). 29, 2023) (“Basis”); NPRM at 44,603.

Controlled Substances 69

Controlled Substances Chemotherapy Dosage Labelling 69

FDA Law Blog: Biosimilars

APRIL 8, 2024

In 2022, the Government Accountability Office (GAO) reported that FDA needed to improve its foreign inspection program and that report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. For generic drug manufacturing facilities specifically, the numbers are 63% and 87%.

Inpatient 59

Inpatient Hospitals Dosage Controlled Substances 59

FDA Law Blog: Biosimilars

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. Statement from President Biden on Marijuana Reform, White House (Oct.

Controlled Substances 95

Controlled Substances Chemotherapy Dosage Labelling 95