We have written on this blog about FDA’s modernization agenda from several angles lately—from the psychedelics Executive Order to the peptide compounding landscape (part 1, part 2)—but here is a storyline that cuts to the operational heart of regulated industry (or at least appears to): FDA has quietly been knocking on facility doors for single-day inspections, and this past Wednesday the Agency told the world about it.

On May 6, 2026, (now former) FDA Commissioner Marty Makary announced at the Food and Drug Law Institute’s (FDLI) annual conference that the Agency has launched a pilot program of one-day “inspectional assessments” for facilities that artificial intelligence (AI) has identified as lower-risk—both for domestic and overseas sites alike...[FDA]