Washington, Feb 1 – The U.S. Food and Drug Administration (FDA) has started accepting requests for its PreCheck pilot program aimed at increasing domestic drug supply. The program is designed to speed up the building and review of drug manufacturing plants in the U.S.
The FDA will select an initial group of pharmaceutical manufacturing facilities this year. The selection will focus on whether the facility meets national priorities, such as the speed of developing products for the U.S. market and innovations in facility design. Facilities producing essential medications for the U.S. market will receive special priority.
Announced in August, the FDA PreCheck program seeks to make it easier to build and run domestic pharmaceutical plants. This program will reduce unnecessary regulatory hurdles and help follow through on President Trump’s executive order from May, which called for more drug manufacturing to move to the U.S.
The program has two phases. In the first phase, there will be more frequent communication with the FDA, covering facility design and construction. In the second phase, pre-application meetings will help streamline the development of manufacturing and quality control processes.
Earlier, the FDA also launched a program to speed up approval times for critical drugs tied to national priorities, including those related to public health and national security. This program promises faster decisions, cutting review times by several months.
However, the FDA has faced delays in reviewing some drugs under this fast-track program due to safety concerns raised by scientists.
