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 two leaders who bring complementary perspectives to women’s health development: Kathleen Lemaitre, MD, FACOG, Executive Director in Medical Affairs and board-certified OB/GYN, and Stacey Ayres, PhD, Vice President, Regulatory Strategy. Together,...