Applied Clinical Trials-10-01-2016

Applied Clinical Trials

PDUFA VI Promotes Patient Views, Innovative Trials

October 01, 2016

News

25

10

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.

Health Technology Assessment: Europe Peers Into the Mist

October 01, 2016

View from Brussels

25

10

New actions underway seek to find a consensus on the role of HTAs in the decision-making chain, including with clinical trials.

Europe’s New Clinical Trials Landscape Looms Large

October 01, 2016

News

25

10

The discussion on the main characteristics and implementation of the new Clinical Trials Regulation is heating up in Europe.

FDA Includes First PRO Measure for COPD

October 01, 2016

News

25

10

Updated guidance incorporates the use of a patient-reported outcomes questionnaire-which could enable more endpoints and greater patient stratification for COPD trials.

Applied Clinical Trials, October/November 2016 Issue (PDF)

October 01, 2016

Issue PDF

25

10

Click the title above to open the Applied Clinical Trials October/November 2016 issue in an interactive PDF format.