News dal mondo

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US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry

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]

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FIS di Montecchio Maggiore accelera il percorso di decarbonizzazione industriale

Fabbrica Italiana Sintetici (FIS) di Montecchio Maggiore, tra i principali operatori globali nello...

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FIS accelera sulla sostenibilità: biometano e taglio del 63% delle emissioni entro il 2035

FIS, tra i principali operatori mondiali nello sviluppo e nella produzione di principi attivi farmaceutici...

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US FDA investigator, experts seek to dispel misperceptions around 483s

Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should...

26

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AIFA - Aggiornate le Q&A sui processi autorizzativi AIC

L'Agenzia ha aggiornato il documento Q&A sui processi autorizzativi relativi a procedure nazionali,...