Zdrowie i gospodarka · 11/09/2023

FDA Announces Second Year of Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program

The FDA is announcing the second year of its Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program, which aims to expedite the development of investigational new drug applications by facilitating earlier patient access to products with significant clinical benefits. The program, which is open to a limited number of applicants, will explore science- and risk-based regulatory approaches to accelerate CMC development and readiness.