IGT Applauds FDA’s Draft Framework to Speed Individualized Therapies, Urges Continued Alignment of Regulation with Breakthrough Treatments for Unmet Needs

The U.S. Food and Drug Administration (FDA) this week released a draft Plausible Mechanism Framework for recognizing the value of accelerating development for individualized therapies for rare and ultra-rare diseases. The draft guidance tackles a long‑standing barrier that has delayed access to potentially life‑saving treatments for people with rare conditions and proposes new ways to spur rare‑disease innovation through clear scientific criteria, closer regulatory collaboration, real‑world...