NIH and FDA will conduct a comparative analysis of "the number of serious adverse events in human gene therapy trials reported to each agency," outgoing NIH Director Harold Varmus, MD, said in a Dec. 1 letter to Senate Health/Public Health Subcommittee Chair Frist (R-Tenn.).

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