Reforming Paediatric Drug Regulations in Canada: A Clinical and an Access Imperative
Charlotte Moore Hepburn,
Allison A. Chang,
Deborah M. Levy
Abstract:Children deserve the same high standards for drug safety, efficacy and access as adults. Unfortunately, Canada lags behind leading international regulators in implementing reforms to ensure access to paediatric medications. Paediatric regulations, also known as paediatric rules in the US, include a mandate to submit paediatric data in all new drug applications
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