Historic Output Of Disease-Specific Guidances Is Among Gottlieb's Legacies At US FDA
A Pink Sheet analysis illustrates how the outgoing commissioner enhanced FDA's ability to facilitate the further development of innovative drugs.
You may also be interested in...
US FDA plans new guidances on real-world data, clinical trial statistics, and patient input in coming this year.
Update of 2007 guidance includes discussion on use of newer endpoints and clarifies that oncology endpoints can serve different purposes.
An industry veteran, Stein has been with agency for only two years; Bob Temple becomes powerful OND "consultant."