Making Sense of FDA’s Expedited Drug Approval Pathways and Designations – for the Non-Regulatory Professional

ByJeff Riegel

One of the fundamental responsibilities of the US Food and Drug Administration (FDA) is to approve effective medicines for people who need them, while upholding high standards for safety. That mission also demands that the FDA work efficiently and not delay approval of life-saving medical advances. Today, the FDA is reviewing applications for approval of…

Can You Predict Whether You Will Face an FDA Advisory Committee?

ByProEd Regulatory

The US Food and Drug Administration (FDA) review of drugs, although guided by broad standards, remains individualized. Each drug or drug class faces unique challenges during the FDA review phase – thus no two reviews are exactly the same. Each review division within the FDA has its own approach, and evaluations often differ among the…