08/28/2025

FDA Program Aims to Expedite Domestic Drug Manufacturing

The Food and Drug Administration (FDA) announced a new initiative called "FDA PreCheck," designed to accelerate the construction and review of domestic drug manufacturing facilities. The goal is to boost the U.S. drug supply by streamlining the facilities’ review process and eliminating unnecessary regulatory hurdles. The program uses a two-phase approach to help companies. The first phase focuses on frequent communication with the FDA during a facility's design and construction, while the second phase offers pre-application meetings and early feedback to streamline the development of manufacturing and quality control processes. While details are still being developed by the FDA, ASCO is closely following this initiative, as we urged Congress to incentivize U.S. manufacturing in Dr. Gralow’s testimony before the Committee on Ways & Means in 2024.