Archives for January 30, 2013

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FDA Warns Taiwanese Drug Manufacturer Over GMP Violations

By Zachary Brennan

As the Food and Drug Administration (FDA) ramps up its inspections of foreign pharma manufacturers in an attempt to root out GMP inconsistencies and faulty processes, a recent warning letter to Taiwanese manufacturer Beanne Chemical may serve as an...

Groups Question Overlap, Redundancy in FDA Draft Guidance on IRBs

By Zachary Brennan

The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial sponsors or CROs.