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12

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US FDA Commissioner Makary Renews Tough Talk About Instituting Unannounced Foreign Inspections

Foreign drug manufacturers are having a time of it these days. On top of the confusion and controversy caused by tariffs, layer FDA’s increasingly aggressive and renewed promises to dramatically expand its foreign drug inspection program. These moves are potentially a potent one-two punch of compliance headaches that could reshape the international drug manufacturing landscape. A coming court ruling on tariffs will be public, but the results of any promised foreign inspection buildup may take years to compile and fully understand. That isn’t stopping Commissioner Marty Makary from talking tough about changes he wants to see happen in this space...[FDABlog]

11

Nov

EDQM clarifies the stepwise process to getting a CEP or having a change approved

he European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a new document...

06

Nov

AIFA - Nuovo servizio online GMPMED per il riconoscimento dell’idoneità ad esercitare la funzione di Persona qualificata dal 1 dicembre 2025

?Data di avvio: 1° dicembre 2025 AIFA Digitalizza ed automatizza la gestione delle istanze per il...

05

Nov

GMP EU per Sostanze Attive e Medicinali Veterinari

Regolamento di esecuzione (UE) 2025/2154 della Commissione del 17 ottobre 2025 che stabilisce la buona...

05

Nov

Italia: punto di riferimento nella lotta alle carenze e al crimine farmaceutico

Domenico Di Giorgio (AIFA) spiega  come l'Italia stia guidando progetti europei per la mitigazione...

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