What the New FDA PreCheck Program Means for Drug Manufacturers

Introduction 

Announced on August 7, 2025, the FDA PreCheck program is a new initiative aimed at strengthening the domestic pharmaceutical supply chain by improving regulatory predictability and helping manufacturers build drug production facilities in the United States.  

For companies operating in or entering the U.S. market, this program could streamline the process of getting facilities ready for production while reducing potential delays in regulatory review. 

If you’re planning to manufacture in the U.S., it’s worth understanding how the FDA PreCheck program works and how it might fit into your compliance and production strategy. Keep reading to learn more about its phases, requirements, and industry impact. 

Why FDA PreCheck Was Launched 

More than half of pharmaceuticals distributed in the U.S. are manufactured overseas. In addition, only 11% of active pharmaceutical ingredient (API) manufacturers are based domestically. This heavy reliance on foreign sources is viewed by the FDA as a risk to both supply chain stability and national security. 

The program was developed in response to Executive Order 14293, Regulatory Relief to Promote Domestic Production of Critical Medicines. This directive encourages FDA to eliminate unnecessary regulatory requirements, streamline review processes, and improve communication between manufacturers and the agency. 

The overall goal is to create a more predictable and efficient path for building compliant drug manufacturing facilities in the U.S. By doing so, FDA hopes to reduce dependence on foreign production and strengthen the resilience of the American drug supply. 

The Two Phases of FDA PreCheck 

1. Facility Readiness Phase

This phase focuses on early engagement between the manufacturer and FDA during key development stages, such as facility design, construction, and pre-production. 

• Companies are encouraged to submit a facility-specific Type V Drug Master File (DMF) containing details like site layout, Pharmaceutical Quality System (PQS) elements, and Quality Management Maturity (QMM) practices. 
• This DMF can be referenced in a drug application, helping to streamline later submissions. 

2. Application Submission Phase

Here, the emphasis shifts to the Chemistry, Manufacturing, and Controls (CMC) section of the drug application. 

• Manufacturers can request pre-application meetings to receive early feedback from FDA. 
• The aim is to address potential issues before formal submission, potentially reducing review times. 

What This Means for Manufacturers 

While participation in the FDA PreCheck program is voluntary, it offers several potential benefits for companies looking to establish or expand U.S. drug manufacturing capacity.  

Beyond regulatory efficiency, it can also help manufacturers build stronger relationships with FDA reviewers, anticipate potential compliance risks earlier, and align facility design with the latest quality and safety expectations. 

Here’s a closer look at the key advantages it can offer: 

• More structured and frequent communication with FDA during facility development. 
• Opportunities to resolve compliance issues before application submission, reducing costly rework. 
• A potentially faster and smoother review process for manufacturing-related sections of drug applications, helping companies bring products to market with fewer delays. 

Upcoming Public Meeting 

FDA will host a public meeting, Onshoring Manufacturing of Drugs and Biological Products, on September 30, 2025, from 9:00 AM to 4:00 PM ET at the FDA White Oak Campus in Silver Spring, Maryland, with virtual participation also available.  

The meeting will include a presentation on the draft FDA PreCheck framework, followed by stakeholder discussions and an exploration of onshoring challenges. For details or to register, visit the FDA meeting page.