With members of the Patient-Centered Outcomes Research Institute’s Methodology Committee expected to be named by early in 2011, one area where they could start to improve comparative effectiveness research is in providing solid guidance for conducting observational studies.

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials