Drug Liver Toxicity Risk Could Be Monitored In Extended Phase III - Temple
Executive Summary
Phase III studies could be extended to monitor the hepatotoxicity risk of drugs in development, FDA Office of Medical Policy Director Robert Temple, MD, suggested during a Feb. 13 workshop on liver toxicity.
You may also be interested in...
PhRMA/FDA Hepatox Group Wants Research On Liver Monitoring
Actelion's pulmonary hypertension agent Tracleer may provide an opportunity for FDA and industry to test new approaches for management of liver toxicity
PhRMA/FDA Hepatox Group Wants Research On Liver Monitoring
Actelion's pulmonary hypertension agent Tracleer may provide an opportunity for FDA and industry to test new approaches for management of liver toxicity
Post-Marketing Hepatotoxicity Drug Withdrawals Subject Of FDA Study
FDA's Center for Drug Evaluation & Research is planning to conduct a detailed re-examination of NDA data sets for drugs withdrawn due to post-marketing liver toxicity