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Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

Pharma/fine chemicals roundup—8 January 2014

4:52 AM MST | January 8, 2014 | Deepti Ramesh

FDA and European Medicines Agency team up for facility inspections for generics The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA; London) announced that they will conduct joint facility inspections for generic drug applications submitted to both agencies. They launched a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. Studies submitted for generic drug applications must demonstrate scientifically that a generic drug is ‘bioequivalent’, which...

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