Current Edition

FDA Marks Milestone in Patient-Focused Drug Development

In this Watch Pages item, Molly Fellin Spence, a medical and
regulatory writer for the Cortellis database and AdComm Bulletin
at Clarivate Analytics, discusses how the US Food and Drug
Administration (FDA) has surpassed its commitment to obtain
patients’ views in at least 20 disease areas over the course of five years,
during its Patient-focused Drug Development (PFDD) initiative,
scheduled to end in September 2017. In creating the PFDD initiative,
the FDA believed that the human drug and biologic review process
could benefit from a more systematic and expansive approach to
obtaining input from patients who experience a particular disease
or condition.