The Centers for Education and Research on Therapeutics will present the research and education agenda resulting from its five therapeutic risk workshops March 6 at the National Press Club in Washington, D.C., at 9 a.m. Workshops to date have covered risk communication, risk assessment and benefit assessment; risk communication & the media will be held on Jan. 7-8 and risk management on Jan. 13-14. The workshops are co-sponsored by CERTs, PhRMA, AHRQ and FDA (1"The Pink Sheet" July 8, p. 21)...

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