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A House committee is pressing the FDA on how it’s dealing with drug adulteration for economic reasons, citing the infamous 2008 heparin contamination scandal that killed at least 81 and infected hundreds more as a prime example. Read More
Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
New FDA guidance is offering companies a way to test anti-clotting drugs for potentially fatal immune responses without the time or expense of additional clinical trials. Read More