Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In...more
New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients. On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more