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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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ECHA & REACh - SMEs to apply for company size validation before making REACH submissions

The European Commission has adopted the revised REACH Fee Regulation. Micro, small, and medium-sized...

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Changes to e-submission requirements for CEP applications for 1 November 2025

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the requirements...

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US FDA Publishes Filing Checklists to Prevent Submission Delays

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when...

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