Zdrowie i gospodarka · 27/10/2022

FDA Launches Rare Disease Endpoint Advancement Pilot Meeting Program to Speed Up Drug Approval for Rare Diseases

The US Food and Drug Administration (FDA) has established a pilot program to facilitate the development and timely approval of drugs and biological products for rare diseases, including those in children, by providing additional engagement opportunities with the Agency to discuss efficacy endpoint development in rare disease drug and biological product development programs.