A new guidance issued by Health Canada will require drugmakers to answer a series of questions about a particular treatment before deciding whether it needs an investigational drug designation for use in an off-label trial. Drugmakers will be required to detail the risks of off-label use, their reason for not considering the off-label use as a separate trial and explain how the proposed use is in accordance with recognized or current medical practice.
Health Canada issues guidance for off-label use of drugs in studies
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