Shifting priorities at FDA means work on a specific review pathway for combination products has been superseded by implementation of the combo products provision in the 21st Century Cures Act, agency center directors said at a recent hearing in the Senate.
Testifying before the Senate Health, Education, Labor and Pensions (HELP) Committee on March 21, Device Center Director Jeffrey Shuren told Sen. Sheldon Whitehouse, D-R.I., that while FDA is "always open...