Communication, Controlled Substances and Labelling

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Communication

Controlled Substances

Labelling

Health Canada issues new Interim Order to prevent bulk exportation of prescription drugs from Canada

Pharma in Brief

NOVEMBER 29, 2020

of the US Importation Rule, drugs eligible for importation must have received an NOC and DIN in Canada and meet FDA approval conditions, aside from US labeling. Controlled substances, biologics, and certain injectable drugs are not eligible for importation. Interim Order Context.

Controlled Substances

Controlled Substances Labelling Communication Vaccines

OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

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.

Labelling

Labelling Controlled Substances Communication

Pharmacist Digest

Health Canada issues new Interim Order to prevent bulk exportation of prescription drugs from Canada

OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy

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