FDA Launches New PreCheck Program to Lower Regulatory Barriers to Pharma Manufacturing

Under PreCheck, the FDA will communicate more frequently with pharmaceutical companies, helping them as they establish or expand manufacturing sites in the U.S.

The FDA on Thursday launched a new program called PreCheck, in hopes of streamlining the regulatory process for pharma companies ramping up their manufacturing infrastructure in the U.S.

In a prepared statement on Thursday, FDA Commissioner Marty Makary flagged the country’s “overreliance” on overseas drug manufacturing, which he said has “created national security risks.” PreCheck, in this context, will “help reverse America’s reliance on foreign drug manufacturing,” ensuring a “resilient, strong, and domestic drug supply.”

The program operates in two phases. The first, called the Facility Readiness Phase, will allow companies to more frequently communicatewith the FDA “at critical development stages,” as the Thursday announcement put it, such as facility design, construction and pre-production. This stage will also include the use of Drug Master Files, a facility-specific document through which companies provide comprehensive information, including site layout and operations.

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