Seven companies. Two phases. One question every quality professional at those sites is now asking: what does "early FDA engagement" actually require from a quality system that doesn't exist yet.
On June 29, 2026, FDA announced the first cohort of its PreCheck Pilot Program, a new pathway designed to bring pharmaceutical manufacturing back to the United States by getting FDA involved in facility development years before a product application is ever submitted. Amneal, Cellares, Eli Lilly, FUJIFILM Biotechnologies, Kriya Therapeutics, Kyowa Kirin and Regeneron were selected from more than 80 applicants. If your site is building new domestic capacity, or if you're advising one that is, this is worth understanding now, not after a facility is already under construction.
Why this exists
PreCheck traces back to Executive Order 14293, signed in May 2025, directing FDA to reduce regulatory barriers to domestic drug manufacturing. The underlying numbers explain why. More than half of pharmaceuticals distributed in the United States are manufactured overseas, and only 11 percent of active pharmaceutical ingredient manufacturers are U.S.-based. FDA launched the pilot on February 1, 2026, received over 80 requests to participate within a month, and selected the first seven based on an objective scoring rubric weighing product type, facility development stage, timeline to market, and manufacturing innovation.
This is not a relaxation of GMP requirements. FDA has been explicit that PreCheck does not alter existing statutory or regulatory standards. What changes is timing and predictability, not the bar itself.
The two-phase model
Phase 1: Facility Readiness. Before a facility becomes operational, participants get early technical guidance from FDA, including review of facility information submitted through a facility-specific Drug Master File. This is where FDA can flag design, layout or system issues while they're still on paper, not after concrete has been poured.
Phase 2: Application Submission. Once a company is ready to file an NDA, BLA, ANDA or supplement relying on the new facility, PreCheck participants get facility-focused pre-submission meetings intended to support expedited facility evaluation and enable inspections earlier in the review cycle.
The stated goal is straightforward: surface facility issues while they're still cheap and fast to fix, rather than during a pre-approval inspection when a deficiency can delay or derail the entire application.
What this means if you're building a quality system for a new facility
A few implications worth sitting with, even if your site isn't one of the seven.
Facility Readiness review happens before your quality system is fully built out. That's a different exercise than a traditional pre-approval inspection, where FDA is evaluating a functioning quality system against real production history. Early engagement means your documentation, from facility design rationale through to your planned qualification approach, needs to be defensible well before your first qualification run.
The Drug Master File becomes a live conversation, not a one-time filing. Facility-specific DMF review under Phase 1 means the same documentation discipline that normally applies to a completed submission now applies much earlier in the facility's life. Equipment qualification planning, HVAC and utility design rationale, and contamination control strategy for sterile sites all need to hold up under scrutiny before they're finished being built.
Two phases means two different audiences, twice. Phase 1 reviewers are assessing facility readiness in the abstract. Phase 2 reviewers are assessing a specific application relying on that facility. A site that treats these as one continuous conversation, rather than two distinct evaluations with different standards, risks assuming Phase 1 goodwill carries more weight in Phase 2 than it actually does.
The part that doesn't change
Everything else about GMP still applies in full. Equipment still needs IQ, OQ and PQ. Aseptic processing still needs validated media fill programs. Analytical methods still need full ICH Q2(R2) validation. None of that gets streamlined by PreCheck participation. What gets streamlined is FDA's willingness to look at your plans before you've committed capital to them, which is a genuinely different kind of engagement than most sites have had with the agency before.
What to watch next
FDA has said it will continue evaluating the pilot's implementation and assess opportunities for future program development, which suggests this cohort of seven is a test case for a potentially larger initiative, not the final shape of the program. Whether PreCheck expands to a second cohort, and whether the eligibility criteria loosen beyond entirely new facilities to include expansions or modernizations of existing sites, both remain open questions industry groups have already been vocal about.
For now, the practical takeaway is simple: if domestic manufacturing expansion is anywhere on your site's roadmap, PreCheck is worth tracking closely, and the fundamentals that make any facility readiness review defensible haven't changed at all.