US FDA's New Development Science Office Modeled On Modeling Office
Executive Summary
Commissioner Gottlieb, who worked at FDA when modeling and simulation office was created and fostered growth of the techniques, expects that new drug development science office could do the same thing for biomarkers.
You may also be interested in...
Clinical Study Report Release Could Compromise Patient Privacy, Groups Say
US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.
US FDA May Scrap Clinical Study Report Disclosure For New Drug Approvals
The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.
Sharpless Calls For A Nimble, Flexible, More Efficient US FDA
In his first speech to an outside group, Sharpless strikes a collaborative tone, saying he expects to listen to the advice of the FDA bar, as well as his own experts.