Manufacturers of alpha and beta interferon products are requested to submit revised labeling with a black box warning in a Feb. 26 letter from the Center for Biologics Evaluation & Research. The revised labeling should indicate the potential for life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders, CBER says. The black box will be similar to the warning found in labeling for Schering-Plough's PEG-Intron (1"The Pink Sheet" Jan. 29, p. 16)

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