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News from the world

09

Sep

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]

05

Dec

Farmaci essenziali sempre più scarsi: la Corte UE avverte sulle falle del sistema

Arriva dalla Corte dei Conti europea l’ultimo allarme relativo alla carenza dei medicinali, un...

04

Dec

Farmaci critici: l’Europa punta all’autonomia

Perché il Critical Medicines Act può ridurre la fragilità della filiera e l’eccessiva...

02

Dec

FDA Publishes Guidance on Current Good Manufacturing Practice for Medical Gases

The U.S. Food and Drug Administration has published the revised draft guidance for industry, Medical...

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