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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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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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