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 ...

Most anticancer drugs that enter clinical testing in children and adolescents fail to reach late-phase trials or earn pediatric regulatory approval, according to the authors of new research. Over a 15 ...

On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of pediatric drug ...

There are a disproportionate number of medications on the market, needed by pediatric patients, that may never go through a similar level of scrutiny during the FDA approval process as the COVID-19 ...

Global Pediatric Development of Drugs, Biologics, and Medical Devices takes an in-depth look at creating and implementing a global regulatory strategy for bringing pediatric drug products and ...