2016 Controlled Substances Labelling 
FDA Law Blog: Biosimilars
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. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. §
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. § Accordingly, had Taiho marketed the product with labeling containing those errors, that labeling would have been false. sections 331(a) and 352. sections 331(a) and 352.(a)(l),
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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. 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016). 53,688 (Aug. 53,767 (Aug. 21 U.S.C. §
The Thyroid Pharmacist
NOVEMBER 15, 2024
Ozempic is a GLP-1 agonist and is actually marketed as a diabetes drug, but many physicians are prescribing it for weight loss (off label-use). Ozempic’s label warns, “In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. Epub 2016 Oct 5. Published 2020 Jun 18.
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. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.
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