Rare disease regulation reaches “inflection point” with new FDA framework - Pharmaceutical Technology

The tailored framework arrives amid renewed focus on rare diseases across US health agencies. The tailored framework arrives amid renewed focus on rare diseases across US health agencies. A rare disease is a condition that affects fewer than 200,000 people in the US. Credit: Jakub Krechowicz/Shutterstock.com. The US Food and Drug Administration (FDA) has rolled out a new framework to spur development of new therapies for rare diseases, marking the latest initiative carried out by the Trump administration for the group of disorders. In a notice via the Department of Health and Human Services (HHS), the FDA said the new…

Source: Pharmaceutical Technology