FDA’s Drug Repurposing Push Puts 505(b)(2) Strategy in Focus

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 new drug applications (ANDAs), its adoption expanded over time as sponsors recognized its strategic value and FDA refined... The post FDA’s Drug Repurposing Push Puts 505(b)(2) Stra