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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]

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EU: dibattito sulle regole della sicurezza chimica

All’evento organizzato dal gruppo ECR al Parlamento europeo, l’Agenzia europea per le sostanze...

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AIFA: Online il Rapporto sulle Attività dell'anno 2024

Il Rapporto, pubblicato sul portale dell’Agenzia, presenta i dati e le attività principali...

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Critical Medicines Act europeo, nuova proposta di legge per garantire fornitura farmaci e principi attivi

Esponenti del Parlamento europeo insieme alle principali organizzazioni dell’industria farmaceutica...

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EMA opens door to reliance on FDA GMP inspections conducted outside the US

The European Medicines Agency (EMA) has begun accepting the Food and Drug Administration’s (FDA)...

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