Regulators Seek to Reduce ‘Residual Uncertainty’ With Drug Development

As safety continues to be a paramount FDA concern, regulators are looking to minimize “residual uncertainty” associated with drugs. The FDA is asking for larger clinical safety databases, broader assessments of vulnerable populations such as the elderly, the capping of certain risks and prospective assessments of risks, Peter Honig, the founding director of CDER’s Office of Drug Safety, said during a panel at the Galien Forum in New York Sept. 28.
Washington Drug Letter