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The European Commission is again seeking to calculate the potential risks of the plasticizer di(2-ethylhexyl) phthalate in medical devices, saying there is a dearth of conclusive data to support limiting its use. Read More
Viramed Biotech, a German manufacturer of in vitro diagnostics, received a one-observation Form 483 related to an issue with its quality control procedure. Read More
The FDA has warned a Mississippi compounder for not disinfecting its clean room equipment and for other serious manufacturing violations, capping a busy year for the agency’s compounding pharmacy enforcement. Read More
China’s FDA is pledging to impose stronger drug safety regulations, with efforts focused on risk assessments and a risk grading and classification system, as well as initiatives to effectively detect and solve problems. Read More