PhRMA/FDA Hepatox Group Wants Research On Liver Monitoring
Executive Summary
Actelion's pulmonary hypertension agent Tracleer may provide an opportunity for FDA and industry to test new approaches for management of liver toxicity
You may also be interested in...
Drug Studies Should Be Powered For Safety As Well As Efficacy, FDAer Says
Drug studies should be powered to assess safety rather than efficacy alone, FDA Office of Pharmacoepidemiology & Statistical Sciences Associate Director for Science, John Senior, MD said at the Pharmaceutical Education Associates Pharmaceutical Risk Management Workshop in Philadelphia Dec. 9
Drug Studies Should Be Powered For Safety As Well As Efficacy, FDAer Says
Drug studies should be powered to assess safety rather than efficacy alone, FDA Office of Pharmacoepidemiology & Statistical Sciences Associate Director for Science, John Senior, MD said at the Pharmaceutical Education Associates Pharmaceutical Risk Management Workshop in Philadelphia Dec. 9
Aventis Arava Adds Physical Function Claim, Bolded Liver Safety Warning
Arava labeling has been updated to include more explicit liver function monitoring directions