Canadian and US drug approval times and safety considerations - PubMed

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Background: Approval times of new drugs are frequently longer in Canada than in the US, but it has been argued that reducing approval times might lead to unsafe drugs receiving marketing approval. Objective: To compare new drug approval times in Canada and the US over a 10-year period and to relate them to safety discontinuations. Methods: Application and approval dates of all new drugs except diagnostic products, new salts, esters, isomers, and dosage forms of already-marketed drugs, as well as combinations containing previously approved substance

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