Clinical Trial Applications for Biologics and Radiopharmaceuticals (English, HTML)

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Publisher-reported update

2022-06-07

Clinical Trial Applications for pharmaceutical (Schedule F), radiopharmaceutical (Schedule C) and biological (Schedule D) drugs are all regulated under Part C, Division 5 of the Food and Drug Regulations, and therefore all must adhere to the same regulatory requirements. However, biological drugs carry additional risks associated with complexity and variability in manufacturing.

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