• In Canada, numerous medications prescribed to children are used off label and do not
have an age-appropriate formulation.• In the United States and European Union, pediatric …

Children deserve the same high standards for drug safety, efficacy and access as adults.
Unfortunately, Canada lags behind leading international regulators in implementing reforms …

The reason? The pharmaceutical industry generally has not submitted evidence in its
possession supporting safe pediatric doses and dosing intervals to Health Canada. As a …

Background Many medications given to children have no commercially available, age-
appropriate formulations. This leads to manipulation of dosage forms designed for adults …

Children have been classifiedas “therapeutic orphans” for more than 50 years, but the
pediatric community has made important strides toward evidence-based safe and effectivedrugtherapyforchildrenthroughimpr …

Aim For over 15 years, the pharmaceutical industry has been engaged in developing
medicines for children to comply with the European Union (EU) and the United States (US) …

1. Background The introduction of the European Union's (EU) regulation on medicines for
pediatric use [1] in January 2007 represented a significant landmark in the development of …

Drug development is a complex undertaking, not an academic exercise. The key players,
mainly pharmaceutical industry, regulatory authorities and academia, have different logics …

Most prescription medicines in the United States and in other countries are not labeled with
sufficient information for sensible use in the pediatric population, even though many drugs …

Children have a right to the highest attainable standard of health, including the appropriate
treatment of disease (1). Yet children and youth continue to be under-represented in …