Baycol Withdrawal: Did Public Reaction Cause More Harm Than Drug?
The public reaction to the withdrawal of Bayer's Baycol (cerivastatin) may have caused more harm than the toxicity associated with the drug, Duke Centers for Education & Research on Therapeutics Principal Investigator Robert Califf, MD, told a CERTs workshop in Chapel Hill, N.C., Jan. 8
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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