The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.
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Modular containment room at Belfast facility allows studies of biologics and vaccines.
Cloud-computing solutions and software enable researchers to garner insight from large, public-health datasets.
Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.
New design meets new process requirements.
Representatives of national health regulatory authorities from around the world convened in Moscow to discuss ways to harmonize regulatory standards for biotherapeutic medicines.
Evaluation system for single-use bags and assemblies is now available for onsite testing.
New company will focus on inspection, monitoring, and control systems for automated pharmaceutical manufacturing processes.
A personalized drug research and development platform will validate biomarkers for individualized disease treatment for Chinese patients.
Prefilled-syringe line features automation and novel disinfection techniques.
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At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved.
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