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News dal mondo

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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]

26

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Medicines for Europe voices shock at ‘concerted efforts’ to water down CMA

Medicines for Europe has expressed shock at the “concerted efforts” of some Member States...

26

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Ministero Salute - Riportare in Italia la grande produzione farmaceutica di base

Dobbiamo riportare la produzione dei principi attivi in Italia, riportare in Italia o in Europa la grande...

24

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FIS investe 20 milioni per rafforzare la capacità produttiva

Il gruppo che fornisce principi farmaceutici ai principali player globali, controllato da Bain Capital...

24

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EMA: linee guida sulle variazioni per una gestione più efficiente

Comunicazione della Commissione C/2025/5045 - Orientamenti riguardanti i particolari delle diverse categorie...

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