FDA Launches PreCheck Program to Fast-Track Pharma Manufacturing

Over the past few years, the pharmaceutical industry has poured billions into U.S.-based manufacturing facilities, driven by both economic opportunity and an urgent need to strengthen the domestic drug supply chain. Now, the FDA is stepping in with a new initiative aimed at making that process faster, smoother, and more predictable. Announced on August 7, 2025, the program—called FDA PreCheck—offers a fresh approach to how drugmakers interact with regulators as they build or upgrade plants in the United States.

At its core, FDA PreCheck is designed to bring manufacturers and regulators into closer, earlier collaboration. Traditionally, many of the most critical conversations between the FDA and drugmakers happened late in the process, sometimes only after a facility was built and ready to begin production. This could mean delays, unexpected compliance hurdles, and costly redesigns.

Under PreCheck, the dialogue begins during the earliest stages—before construction even starts. Companies can share detailed information about their planned facilities, from architectural layouts to quality control strategies, through a dedicated Drug Master File. This file can later be used to support actual drug approval applications, reducing repetitive paperwork and avoiding duplication of effort.

The program unfolds in two phases. The first focuses on “facility readiness,” offering frequent touchpoints as a site moves from concept to design to pre-construction. The second looks more closely at the manufacturing and quality processes themselves, giving companies the chance to receive feedback before they formally submit applications. By aligning earlier on these critical elements, both the FDA and manufacturers hope to avoid last-minute surprises and shorten the timeline between breaking ground and producing medicine.

FDA Commissioner Marty Makary has positioned PreCheck as a strategic tool for reducing America’s reliance on foreign production and ensuring that the nation can respond more effectively to future public health challenges. The program is also a direct response to a May 2025 executive order that called on the agency to cut unnecessary regulatory delays and streamline plant approvals without compromising safety.

A public meeting to explore the program in more detail is set for September 30, 2025. For pharmaceutical companies watching the shifting landscape of manufacturing, it’s a date worth noting. If PreCheck delivers on its promise, it could mark a turning point—making it faster and less complicated to bring high-quality, domestically made medicines to market, while also reinforcing the resilience of the U.S. drug supply.

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