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The European Medicines Agency and the European Commission published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. 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
The FDA is clarifying that if an institutional review board is found to be noncompliant, the FDA may require the IRB to withhold approval of new clinical studies, stop enrolling new subjects in ongoing studies, and to terminate ongoing studies. Read More
The European Medicines Agency is pairing up with various governments’ policy review boards to streamline consultations with drug companies following a successful test run of the effort. Read More