Why FDA PreCheck Could Change the Game: For years, U.S. pharmaceutical companies have relied on programs like Fast Track and Breakthrough Therapy Designation to accelerate drug development timelines. These programs have helped bring critical therapies to patients faster—but they do very little to address the other side of the equation: manufacturing readiness and reliability. Now, the FDA is introducing a new pilot: FDA PreCheck, aimed not at the molecule itself, but at the infrastructure, quality systems, and manufacturing platforms that bring therapies to life. Here’s why PreCheck may be a better fit for the challenges pharma faces today—and why companies might want to prioritize this over traditional speed-designation programs.
What Is the FDA PreCheck Pilot? The FDA PreCheck pilot, announced in August 2025, is a new initiative designed to strengthen U.S.-based pharmaceutical manufacturing, de-risk regulatory inspections and CMC reviews, and create a streamlined pathway for companies with proven quality systems. Unlike molecule-focused programs, PreCheck is about organizational capability—not a specific product. While the details are still emerging, there will be at least two phases:
Phase 1: Facility Readiness Engagement: Sponsors submit a Type V Drug Master File (DMF) detailing facility design and layout, pharmaceutical Quality System (PQS) and Quality Maturity data. The FDA offers real-time feedback during design, construction, commissioning, and validation.
Phase 2: Application Integration: When an actual drug application is submitted (NDA, ANDA, BLA), the FDA can reference the facility DMF. This enables faster CMC section reviews, fewer inspection surprises, and more confidence in the applicant’s systems.
How Is PreCheck Different from Fast Track and Breakthrough Therapy?
| Feature | Fast Track | Breakthrough Therapy | FDA PreCheck |
|---|---|---|---|
| Focus | Drug/Indication | Drug/Indication with early promise | Facility / Manufacturing Platform |
| Benefits | Early meetings, rolling review | Intensive FDA guidance, rolling review | Early manufacturing engagement, quality-based acceleration |
| Trigger | Clinical need, no good alternatives | Preliminary clinical evidence | Readiness of facility, quality system, onshoring priority |
| Risk | CMC delays still possible | CMC delays still possible | CMC risks mitigated early |
| Strategic Value | Speeds review | Increases FDA collaboration | Builds platform credibility across multiple programs |
Why FDA PreCheck May Be Better for Long-Term Advantage
PreCheck Targets the True Bottleneck: Manufacturing. Both Fast Track and Breakthrough Designation focus on clinical performance—but in many cases, promising therapies still hit delays due to CMC problems. Some stumbling blocks include delayed batch release because of process inconsistencies, incomplete validation packages at submission, post-approval commitments that stall launch. But with PreCheck, those issues are proactively addressed before the application is submitted. Key advantage: Companies don’t just accelerate a drug—they build a replicable framework that speeds all future submissions from the same site.
PreCheck Establishes You as a “Trusted Manufacturer.” Fast Track and Breakthrough are drug-specific. They don’t carry over. But with PreCheck a company’s facility and quality system are reviewed once, in advance. Further, companies can reference the same Type V DMF across multiple applications; FDA reviewers will recognize the platform and quality rigor. Think of it like becoming TSA Pre✓ certified—security isn’t skipped security, but the process is quicker, smoother, and lower risk every time.
CMC Is Now a Competitive Edge: We’ve entered a phase where manufacturing reliability is a differentiator. Why? Supply chain fragility, tariffs and geopolitical risks, and recalls and compliance events in CDMO networks. Fast Track doesn’t protect you from these. PreCheck does—by reinforcing internal quality culture, providing FDA feedback on your system before your product is at risk and incentivizing continuous improvement
PreCheck Supports Resilient, U.S.-Based Supply Chains: The FDA has made it clear: the U.S. must reduce reliance on foreign drug production. PreCheck is tightly aligned with that policy. It’s open only to facilities based in the United States (as of the pilot). The program is designed to reward companies investing in domestic capacity. It aligns with Executive Order 14293 on supply chain resilience. That’s not just regulatory—it’s strategic positioning. For investors, partners, and government buyers, PreCheck is a signal of reliability and security.
Risks and Limitations of PreCheck: PreCheck isn’t free from risk. Let’s be honest:
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- High Initial Resource Investment: Preparing a full Type V DMF takes time, cross-functional coordination, and discipline. Not every company has the internal bandwidth or maturity level to do this well.
- It’s Still a Pilot: Participation is limited. There is no guarantee of full program continuity after the pilot ends.
- Limited to U.S. Facilities: Global companies may find the geographic restriction limits ROI—unless reshoring is part of their strategy.
- No Clinical Acceleration: Unlike Breakthrough or Fast Track, PreCheck doesn’t reduce the time for clinical development or data collection.
- It’s about CMC, manufacturing, and inspection readiness.
How Companies Should Evaluate Participation in the Program. Companies must ask themselves:
- Are we building or modifying a U.S.-based facility?
- Are we launching multiple products from the same manufacturing platform?
- Do we face frequent CMC or inspection challenges?
- Do we want faster time to market without surprises?
- Do we have internal maturity (or partners) to build a Type V DMF?
If yes to most, PreCheck may be more valuable than Fast Track.
Regulatory Synergy: The Power of Combining Designations: Here’s the secret: PreCheck and Fast Track/Breakthrough may not be mutually exclusive. Imagine: A program’s molecule gets Fast Track or Breakthrough Designation; the facility is in the PreCheck program. FDA reviewers see a high-priority drug and a trusted manufacturing setup. That’s a powerful signal—and potentially game-changing in review time, inspection frequency, and launch success.
Final Thoughts: PreCheck Is a New Kind of Acceleration: The traditional playbook of Fast Track and Breakthrough Therapy helped pharma navigate the speed demands of high-need therapeutics. Today’s challenges are broader with more fragile supply chains, dependence on overseas partners, and regulatory uncertainty in manufacturing. FDA PreCheck answers those challenges, focusing not on what you’re making but how and where you’re making it. It’s a bold step toward rewarding quality systems, proactive planning, and manufacturing resilience. And for companies that can meet the bar, it may be the single best investment they can make to unlock sustainable speed, credibility, and competitive edge.
Are you planning to build a new facility, expand your capacity, or invest in your CMC team? Now’s the time to evaluate your program’s readiness for this next pilot. Connect with our experts at Syner-G for a free consultation, and discover how we can help you establish a strong PreCheck program that drives long-term success.
