Overview

• The FDA announced PreCheck on August 13 to streamline approvals for new U.S. pharmaceutical manufacturing sites.
• The Facility Readiness and Application Submission phases offer early agency engagement on facility design and chemistry, manufacturing and controls reviews.
• PreCheck aims to reduce reliance on overseas drug production, addressing data that show over half of U.S. pharmaceuticals are made abroad.
• Pharmaceutical companies such as AstraZeneca, Biogen and Eli Lilly have revealed recent U.S. plant investments to leverage the expedited pathway.
• A public meeting on Sept. 30 will flesh out program details, as precise time-savings and requirement modifications remain unspecified.