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 ...

Introduction Pediatric Pharmacology Disasters Testing Drugs in Children Legal and Regulatory Developments: Pediatric Pharmacology in the United States References Legal and Regulatory Developments: ...

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 ...

The U.S. Food and Drug Administration (FDA) has issued two new draft guidance documents on pediatric drug development and exclusivity, most notably clarifying that, under a new proposed policy that ...

Please provide your email address to receive an email when new articles are posted on . The Research to Accelerate Cures and Equity Act led to an increase in required pediatric studies for recently ...

Pediatric clinical trials commonly experience recruitment challenges including limited number of patients and investigators, inclusion/exclusion criteria that further reduce the patient pool, and a ...

One of the earliest disasters in modern pediatric drug therapy has, unfortunately, been the most repeated. In 1937, 2 years after adults had begun benefiting from sulfa antibiotics, an elixir of ...