FDA Law Blog: Biosimilars
JULY 31, 2023
Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. By Larry K. 78,282 (Dec.
FDA Law Blog: Biosimilars
AUGUST 8, 2024
Comments ranged from single sentence declarations to lengthy, cogent treatises, expounding on whether to reschedule marijuana from schedule I to schedule III or another schedule under the federal Controlled Substances Act (“CSA”), to leave marijuana in schedule I, or to deschedule altogether. 21 U.S.C. § 812(c)(c)(10). 21 U.S.C. §
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FDA Law Blog: Biosimilars
JUNE 3, 2025
However, the 2022 Clinical Practice Guideline, which updated the CDCs 2016 Guideline, notes that its recommendations are voluntary and intended to be flexible to support, not supplant, individualized, patient-centered care. Recommendation 1. at Background.
FDA Law Blog: Biosimilars
MARCH 10, 2024
Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.
Med Ed 101
MAY 10, 2017
It is a tough question, much like opioid, benzo, stimulant, or any other controlled substance. Recognizing the risk of abuse potential, in August 2016, Minnesota added it to its list of drugs that need to be reported on […]. The post How to Handle Gabapentin Abuse appeared first on Med Ed 101.
FDA Law Blog: Biosimilars
APRIL 22, 2024
The Senators implore efforts to reschedule marijuana be driven by facts, “not the administration’s favored policy,” and question whether rescheduling would violate the Controlled Substances Act (“CSA”) and U.S. 811(d) required classification of marijuana as a schedule I or II substance to comply with U.S. 811(d) and U.S.
FDA Law Blog: Biosimilars
APRIL 21, 2024
Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § After all, as we posted in 2016 , there have been approval date resets under certain circumstances. But there may be more out there.
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