View from Washington

Oct 01, 2016
Applied Clinical Trials
FDA and industry have agreed on a set of recommendations for revising the drug user fee program, which now sits before Congress as U.S. election nears.
Aug 01, 2016
Applied Clinical Trials
The need to revise the design, performance and interpretation of clinical research to reflect changing methods and standards is drawing increased attention.
Jun 01, 2016
Applied Clinical Trials
FDA's breakthrough drug initiative has proven successful to date, but challenges remain in addressing the expectations and patient concerns surrounding candidates in this program.
Apr 01, 2016
Applied Clinical Trials
FDA's new commissioner advocates for a "learning healthcare system" and less-complex clinical trial models that tap efficiencies in study design and enrollment.
Feb 01, 2016
Applied Clinical Trials
Agency is asking sponsors to propose demonstration projects that test the use of electronic health records and standards-based technology solutions. Ensuring trials assess new drugs in diverse patient populations is also a priority focus.
Dec 01, 2015
Applied Clinical Trials
These three areas will be at center of drug development discussions in the year ahead.
Oct 01, 2015
Applied Clinical Trials
An update to the federal government's "Common Rule," which protects patients involved in research, is in the works.
Aug 01, 2015
Applied Clinical Trials
The "Cures" bill and PDUFA IV are the latest measures pushing for more systematic inclusion of patient views into drug development.
Jun 01, 2015
Applied Clinical Trials
Agency concerned about how proposals in "Cures" bill will be crafted and implemented.
Apr 01, 2015
Applied Clinical Trials
The productivity of the U.S. biomedical research enterprise is undergoing a broad re-examination.
native1_300x100
lorem ipsum