CMAJ| JULY 31, 2017| VOLUME 189| ISSUE 30 E991 to induce drug companies to study
and market pediatric indications for their drugs. 9 These mechanisms involve, on the one …

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 …

Children continue to be underrepresented as participants in clinical trials, limiting the
evidence available to guide treatment decisions. Among new interventional trials registered …

LAWS REQUIRING OR ENCOURAGING pharmaceutical companies to conduct pediatric
clinical trials of medications are helping clinicians gain useful information, according to a …

The Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act
(PREA) are companion legislation acts that together have resulted in a significant increase …

Paediatric drug development faces unique challenges because of two opposing concerns.
On the one hand, the fundamental differences between growing and developing children …

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 …

• 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 …

In the current era of evidence-based medicine, physi-cians caring for children struggle to
define a standard of care with drugs that have not been evaluated in children. Because …

Purpose Greater than 50% of drugs lack pediatric labeling information, resulting in
widespread “off‐label” use in children. To increase pediatric prescribing information, the …