Early Insights from Forge Regulatory Experts on the New FDA PreCheck Program

Early Insights from Forge Regulatory Experts on the New FDA PreCheck Program

Authors: Forge Regulatory Team

FDA PreCheck is a newly launched initiative designed to accelerate and streamline the regulatory pathway for establishing drug manufacturing facilities in the U.S. It consists of a two-phase approach: the Facility Readiness Phase, and the Application Submission Phase. The program was created in response to Executive Order 14293, which aims to bolster domestic pharmaceutical manufacturing and reduce the U.S.’s reliance on foreign production.

Here, and following the FDA’s planned public meeting on September 30, 2025, Forge experts weigh in on key takeaways.

What’s the big picture?

PreCheck is designed to speed up and smooth out FDA interactions with U.S.-based manufacturing facilities, making it easier to produce pharmaceuticals in the U.S.

What does this mean specifically for cell and gene therapy CDMOs like Forge?

This program may grant CDMOs the unprecedented opportunity to engage with the FDA before a client developer has reached a marketing application, allowing the manufacturer to de-risk the developer’s application by reviewing operations and quality systems with the agency in advance.

Why should gene therapy developers care?

• Fewer roadblocks, earlier clarity – More frequent FDA touchpoints during facility design and build mean fewer late-stage surprises that can derail development timelines.
• More predictable timelines – Pre-application meetings and early regulatory feedback help developers keep CMC milestones on track and avoid unexpected delays.
• Better supply chain security – With stronger incentives to build U.S. facilities, developers gain more reliable domestic manufacturing options, reducing risk and ensuring programs stay on course. 

What does the FDA want feedback on in its PreCheck proposal?

The FDA is seeking stakeholder input to better understand barriers and opportunities for domestic pharmaceutical manufacturing. Specifically, the agency is asking – and our initial perspective on each. 

• What are the most significant regulatory hurdles to establishing a new U.S. manufacturing facility?
  For many, the largest barrier is the upfront expense of building a facility that meets commercial manufacturing regulations.
• Which elements of the FDA’s PreCheck proposal would most help new facilities?
  One promising feature is the option for pre-submission meetings, a chance to resolve issues early and expedite regulatory assessments.
• Are there additional considerations the FDA should include?
  Yes. Stakeholders suggest including special considerations for advanced therapy medicinal products (ATMPs), particularly for rare diseases, where unique challenges exist in scaling and compliance.

Check back after September 30 for our full breakdown and further insights after the FDA’s public meeting!