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...
Stacey Ayres
In recognition of Women’s History Month, we spoke with a leader who brings complementary perspectives to women’s health development: Stacey Ayres, PhD, Vice President, Regulatory Strategy. She reflected on how women’s health research has evolved — and what it will...