2021 Controlled Substances Labelling 
Pharma in Brief
JANUARY 7, 2024
Eligible drugs must: (i) be approved by Health Canada; and (ii) meet FDA-approval conditions for a drug currently marketed in the US (aside from US labeling). Biologics, controlled substances, and certain other drugs are not eligible for importation. 01.014.13).
FDA Law Blog: Biosimilars
AUGUST 16, 2023
Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This seems to suggest that FDA expects this type of outcome claim to be included in labeling.
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. Published 2021 Apr 1. 2010;1(3):117-128.
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