Inside FDA’s PreCheck Public Meeting: Why It Matters for CGT Developers
Authors: Forge Regulatory Team
On September 30, 2025, Christopher Shilling, Chief Regulatory Officer at Forge Biologics, traveled to Washington, D.C. to represent the gene therapy manufacturing community in discussions on the FDA’s newly proposed PreCheck program, part of broader efforts to advance onshoring of pharmaceutical and biologics manufacturing. He was one of just 30 manufacturers invited to participate on the panel, which covered topics spanning generics, small molecules, biologics, and gene therapy, underscoring Forge’s role as a leading U.S.-based CDMO helping shape the regulatory landscape for advanced therapies.
The session focused on how the FDA’s PreCheck program could accelerate facility readiness and oversight to bolster U.S. manufacturing. The dialogue showcased industry enthusiasm and the FDA’s openness to partnership.
Key Discussion Themes
- From “Inspection” to “Partnership”
One of the most striking themes was the shift toward earlier dialogue between the FDA and manufacturers. Inspections after years of development without prior visits to a facility are often binary: did you meet the code, yes or no? The proposed PreCheck framework, by contrast, would allow the FDA to engage earlier in a more collaborative, partnership-driven way while programs are still in development, fostering greater transparency and alignment.
Another key topic was the panel’s recommendation to ‘de-couple’ facility inspections from the tight, high-pressure timelines driven by the Prescription Drug User Fee Act (PDUFA) date, which is triggered only after a market application is submitted. Allowing the Agency to “certify” facilities in advance would promote predictability and help ensure that CMC considerations do not become a gating factor for market approval.
- Expanding Eligibility
Participants emphasized that PreCheck should apply not only to new facilities but also to those expanding or recently completed. Chris highlighted that companies like Forge, which continue to invest in facility growth, should be able to benefit from PreCheck and its CMC engagement opportunities. - Clarifying Scope and Limitations
There was discussion on whether PreCheck might be perceived as a shortcut to regulatory approval. PreCheck is not intended to serve as a fast track program, but rather as a structured engagement tool that aims to reduce regulatory burden, builds regulatory confidence for manufacturers, and enhances efficiency. While potential efficiencies may include fewer or earlier inspections, the real value lies in fostering greater predictability in filing acceptance. - Type V DMFs and Data Sharing
Another focus of the discussion was whether a Type V Drug Master File (DMF) could be leveraged as a framework for PreCheck. FDA acknowledged some limitations of the Type V pathway but indicated openness to carving out the appropriate use cases. Industry participants emphasized that such a DMF could enable manufacturers to allow FDA reviewers access to facility and quality related information well in advance of the product-specific market application for a new drug, creating a clearer mechanism for FDA engagement. - FDA Resources and Practicality
A practical question raised by participants and echoed by Chris, was whether the FDA is sufficiently resourced to execute PreCheck alongside its existing responsibilities. Success will depend on the FDA having the staff and expertise to manage earlier and more frequent engagements. The FDA acknowledged these constraints but could not make any further commitment or comment.
Why CGT Developers Should Care
For developers in cell and gene therapy, regulatory predictability around facility readiness is critical. The timelines to advance therapies for rare and ultra-rare diseases are already compressed. By streamlining inspections, clarifying expectations, and enabling platform-level efficiencies, FDA PreCheck has the potential to remove uncertainty from regulatory acceptance of new manufacturing facilities.
Forge’s Role in Shaping the Future
As a U.S.-based gene therapy CDMO, Forge is committed to engaging early with regulators on policies that directly affect our clients and the patients they serve. Forge’s participation in the FDA’s public meeting reinforced our perspective: a more collaborative and transparent partnership with the FDA will help create a more efficient review and approval process for gene therapy products, ultimately benefiting patients.
From urging the FDA to expand eligibility, emphasizing the potential of platform technologies, and proposing new ways to leverage DMFs, Forge is helping ensure that FDA PreCheck works not just for large pharma, but also for the next generation of gene therapies.
The next steps will include written feedback to the FDA through the Federal Register Notice, narrowing and prioritizing proposals for implementation, and continuing the dialogue as the PreCheck framework evolves.
At Forge, we understand that every step toward greater regulatory clarity directly impacts patients waiting for potentially life-changing treatments. By representing the voice of the CGT sector in discussions like this, Forge is helping to build a stronger, more predictable regulatory pathway for gene therapy manufacturing, ultimately improving how advanced therapies reach patients worldwide.
