The U.S. Food and Drug Administration’s (FDA) renewed focus on drug repurposing is bringing fresh attention to a regulatory pathway that has quietly shaped drug development for decades: 505(b)(2). Starting out as a critical mechanism bridging the gap between traditional 505(b)(1) new drug applications and abbreviated...
Angela Drew
Determining the right regulatory pathway for a drug product is a critical early decision that can shape the entire development strategy. While many products may appear to fit the generic model, nuances in formulation, dosage form, route of administration, or...