Home / Business and Economy / FDA Pilot Cuts Drug Facility Review Time
FDA Pilot Cuts Drug Facility Review Time
30 Jun
Summary
- FDA PreCheck program accelerates new manufacturing facility reviews.
- Up to 14 months could be saved by participating companies.
- Seven companies, including Eli Lilly and Regeneron, are selected.
The U.S. Food and Drug Administration has initiated the PreCheck pilot program, a new endeavor designed to accelerate the review of domestic pharmaceutical manufacturing facilities. Seven prominent companies have been selected to participate in this groundbreaking initiative.
Among the chosen participants are industry leaders Eli Lilly and Regeneron, alongside Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin. This diverse group will be instrumental in testing the program's effectiveness.
The PreCheck program allows FDA regulators to commence reviews of manufacturing facilities while they are still under construction. This proactive approach enables the early identification and correction of potential issues, a process the FDA estimates could shave up to 14 months off project timelines.
This program represents a significant step by the U.S. Department of Health and Human Services to support and expedite pharmaceutical manufacturing within the United States. The aim is to streamline the path from production to market availability.
