The Pediatric Research Equity Act aims to close the gap in pediatric drug testing but faces significant delays in study completion. Rare disease designations exempt nearly half of new drugs from ...

Please provide your email address to receive an email when new articles are posted on . No drugs approved between 2017 and 2020 were subjected to post-approval pediatric testing requirements. After ...

Please provide your email address to receive an email when new articles are posted on . Out of 323 drugs, only 10% completed testing in children before receiving FDA approval. Rare disease ...

Changes in the regulatory environment in the United States and European Union have the potential to advance the concept of precision medicine to children with cancer. Preclinical testing of targeted ...

There are critical gaps in biosimilar adoption for pediatric patients, focusing on safety, regulatory challenges, and the ...

Compassionate use can be the best option for patients who seek treatment and cannot participate in a clinical trial and who have no satisfactory therapeutic alternatives. Pediatric oncologists should ...