By Ana Mulero  The US Food and Drug Administration (FDA) adopted its version of the International Council for Harmonization’s (ICH) addendum on pediatric drug development, with a substantial amount of new information added to the policy principles initially set forth in 2000. The agency’s guidance—released in April this year and based on the August 2017 […]

by Regulatory Affairs Professional Society As part of an upcoming public workshop, the US Food and Drug Administration plans to learn about recent developments in pediatric pharmacovigilance from participants’ perspectives. The goal is to “expand the conversation,” with updates gathered at the public workshop—set for 14 September—on barriers to using new solutions in pharmacovigilance. This […]

by from the Food and Drug Administration’s Office of Pediatric Therapeutics, Division of Pediatric and Maternal Health, and Division of Neurology Products The Food and Drug Administration (FDA) recently approved Gilenya (fingolimod), a sphingosine 1-phospate receptor modulator, as the first treatment for relapsing forms of multiple sclerosis (MS) in pediatric patients 10 years of age […]

by UT Southwestern Medical Center A first-of-its-kind drug targeting a fused gene found in many types of cancer was effective in 93 percent of pediatric patients tested, researchers at UT Southwestern’s Simmons Cancer Center announced. Most cancer drugs are targeted to specific organs or locations in the body. Larotrectinib is the first cancer drug to […]

June 2018: The Food and Drug Administration’s Office of Pediatric Therapeutics, the Division of Pediatric & Maternal Health, and the Center for Biologics Evaluation and Research New pediatric information was added to the labeling of 48 drugs, two vaccines, two blood products and one allergenic product for a total of 53 products.  The approved agents to treat […]