The FDA wants to “pre-check” factories before the medicine exists

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On February 1, 2026, the U.S. Food and Drug Administration opened applications for PreCheck — a pilot designed to make it faster (and less uncertain) to build new drug and biologics plants on American soil.

At first glance, this sounds bureaucratic: a new process, a new form, a new acronym. But PreCheck is something more interesting. It is the clearest sign yet that Washington is treating pharmaceutical manufacturing as infrastructure — closer to semiconductors than to paperwork.

For decades, regulators have largely met new factories at the finish line: when the walls are up,

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