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09

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US internal Mock DEA-Style and Mirror Inspections and Audits: Trust But Verify

Drug Enforcement Administration (“DEA”) diversion investigators conduct random, unannounced cyclic inspections of “non-practitioner” registrants (manufacturers, distributors, importers, exporters and narcotic treatment programs) about every three years.  Investigators also randomly inspect hospitals, pharmacies and practitioners.  With civil monetary penalties for violations of recordkeeping and reporting requirements adjusted for inflation up to $19,246 per violation, periodic mock DEA-style and mirror inspections and audits are more important for registrants than ever....[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...

15

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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...

14

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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...

10

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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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