Generic drug manufacturers could face new regulatory requirements from FDA

FDA recently announced critically important information for all generic drug manufacturers which will require generic drug manufacturers to develop and implement safety-related changes to their labeling. If/when implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labeling updates. Prior to this new rule generic companies could only change…

FDA Risk Evaluation Workshop Announced

The Food and Drug Administration (FDA) announced a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.” The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the…