In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration (FDA) recently issued a final guidance document clarifying how the agency intends to regulate clinical decision support (CDS) software.
How has this document caused confusion for industry? How can companies respond?
In an effort to address the challenge of increasing drug prices for patients and families, the U.S. Food and Drug Administration (“FDA”) and the U.S. Department of Health and Human Services (“HHS”) recently outlined a proposal for facilitating the importation of pharmaceuticals originally intended for foreign markets. The Safe Importation Action Plan (the “Action Plan”),