Woodcock Lays Out CDER Agenda Following 21st Century Cures

Director Janet Woodcock laid out her priorities for the coming year, in the wake of the 21st Century Cures Act becoming law earlier this week.

The Cures Act authorizes an additional $500 million over 10 years for the FDA, to fund work on seeking patient input, biomarker qualification, continuous drug manufacturing, novel clinical trial designs, and using real world evidence in regulatory decisions.

The act also grants the agency additional hiring authority, and allows higher salaries to be offered in order to attract reviewers.