The US Food and Drug Administration announced on August 7, 2025, FDA PreCheck, which is a new program in order to strengthen the domestic pharmaceutical supply chain by way of increasing regulatory productivity along with facilitating the construction of manufacturing sites within the United States.
It is well to be noted that more than 50% of pharmaceuticals distributed in the US are manufactured overseas. Moreover, the US is dependent on overseas sources for active pharmaceutical ingredients – APIs. Of the manufacturers that produce APIs that are used in FDA-approved products, just 11% happen to be US manufacturers.
According to Marty Makary, the FDA Commissioner, their gradual over-dependence on foreign drug manufacturing has gone on to create a national security risk. The FDA PreCheck program happens to be one of the many steps that the FDA is taking that can help in reversing the reliance of America on foreign drug manufacturing and making sure that the US citizens have a very resilient, robust, and domestic drug supply.
It is well to be noted that the FDA PreCheck was developed in response to the executive order 14293, which is ‘regulatory relief to promote domestic production of critical medicines’ that directs the FDA to go ahead and streamline the review of domestic pharmaceutical manufacturing and also eradicate regulatory requirements that are unnecessary, while at the same time maximizing the review timeliness along with predictability. The FDA PreCheck program goes on to introduce an innovative two-phase approach in order to facilitate the new US drug manufacturing setups.
Initially, the Facility Readiness Phase offers manufacturers more consistent FDA communication when it comes to critical development stages, which includes construction, facility design, and even pre-production. This phase also helps companies to offer comprehensive, facility-specific information by way of a Type V Drug Master File (DMF), like site operations layout as well as description, quality management maturity practices, and pharmaceutical quality system elements. The facility-specific DMF can then be incorporated by way of reference into a drug application that stands appropriate. Second, the application submission phase centers on streamlining development of the chemistry and manufacturing as well as the control section of the application by way of pre-application meetings as well as early feedback.
Apparently, the FDA is going to host a public meeting, which is titled “Onshoring Manufacturing of Drugs and Biological Products,” on September 30, 2025. At the White Oak campus of the FDA at Silver Spring, Maryland, there is also virtual participation that is available. The meeting is going to feature a presentation of the FDA PreCheck program draft framework along with stakeholder discussions on framework robustness as well as opportunities and also certain discoveries of additional considerations in order to overcome any present onshoring challenges that are relevant to the FDA authority.
