FDA should consider supporting "wild card" pediatric exclusivity which would allow companies to apply patent extensions to a product of their choice in return for performing needed pediatric research, Oncologic Drugs Advisory Committee member Henry Friedman, MD, Duke University Medical Center, suggested.

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