Sep 30, 2025
Introduction
The FDA has recently introduced two initiatives: PreCheck and the Advanced Manufacturing Technologies (AMT) Designation Program. Together, they aim to strengthen U.S. pharmaceutical manufacturing. Both are designed to reduce reliance on foreign suppliers, foster the adoption of innovative approaches, and create more resilient supply chains.
The FDA PreCheck Program
PreCheck establishes a risk-based regulatory pathway to expedite the review of new U.S. pharmaceutical manufacturing facilities. It works in two phases: an early facility readiness phase, where companies can engage FDA during design and construction, followed by an application submission phase that integrates this feedback into the drug application process.
The program promises clearer communication with FDA reviewers, faster and more predictable timelines, and ultimately, greater confidence in domestic capacity. By assessing facilities earlier in development, PreCheck reduces uncertainty for sponsors while advancing the FDA’s broader goal of supporting U.S.-based production.
To introduce the framework and gather stakeholder input, FDA will host a public meeting on September 30, 2025, at its White Oak Campus, with virtual participation available. The meeting will highlight PreCheck’s draft structure and explore challenges to onshoring that remain within FDA’s authority to address.
The AMT Designation Program
Whereas PreCheck focuses on facilities, the AMT program encourages the use of innovative technologies such as continuous manufacturing, digital twins, or process analytical technologies (PAT), that can improve quality, efficiency, and flexibility in drug production.
Sponsors, CDMOs, and technology developers can request FDA designation for specific technologies. Those accepted benefit from enhanced communication with agency experts, early regulatory advice, and a clearer path to adoption. In doing so, AMT fosters innovation while directly supporting efforts to expand capacity and safeguard supply chains.
How They Work Together
PreCheck and AMT are designed to be complementary. PreCheck addresses the readiness and predictability of domestic manufacturing facilities, while AMT provides a framework for advancing new technologies within those facilities. Together, they align with FDA’s broader policy objective of modernizing U.S. pharmaceutical manufacturing and reducing reliance on foreign sources.
By combining early facility engagement with support for advanced technologies, these initiatives have the potential to improve supply chain security, accelerate patient access to critical medicines, and create a more efficient regulatory environment.
Conclusion
The launch of PreCheck and AMT marks a significant step in FDA’s strategy to promote innovation and resilience in U.S. drug manufacturing. For sponsors, contract manufacturers, and technology developers, engaging with these programs offers not only regulatory advantages but also a chance to demonstrate long-term commitment to robust, high-quality supply chains.
At Pharmefex, we help clients navigate these evolving pathways, whether it’s integrating PreCheck into facility readiness plans, aligning CMC strategies with AMT expectations, or preparing inspection-ready dossiers. Our expertise ensures that sponsors can move confidently through these new frameworks, turning regulatory opportunities into competitive advantages.
For more information or to register for the September 30, 2025 public meeting, visit the FDA website or contact PublicEngagement@fda.hhs.gov.