Breakthrough designation streamlines development — especially for private companies 

FDA’s breakthrough therapy designation slashes late-stage development times by about 30%, and is especially effective in helping private companies that lack the resources of their public counterparts, according to a study that was published in Health Affairs.

Created by Congress in 2012, the BTD program is a high-touch approach that provides for intensive guidance from FDA officials aimed at streamlining drug development, ensures attention from senior managers, and provides the benefits of fast-track designation such as rolling submissions. ...