Expedited Pathways/Higher Instance of Safety Related Labeling Changes

Mostaghim et al (BMJ 2017;358:j3837) recently published a study in the British Medical Journal that concludes that “Expedited development and regulatory review pathways can accelerate the availability of new drugs, but drugs approved through these pathways are associated with increased safety related label changes after approval, particularly for the types of changes representing the highest risk warnings. To inform appropriate policy interventions, additional research should explore the causal factors contributing to these different rates.” Click here for the full article and here for help with labeling supplements or pharmacovigilance.