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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
The FDA has approved a supplemental application for abortion drug Mifeprex, updating the label to lower the dosage and extend the usage period to 70 days gestation from 49. Read More
Pricing transparency is a key ingredient in bringing down prescription drug costs, according to a policy paper from the American College of Physicians. Read More