Hep B Trials Should Use Composite Endpoint, Not Just Histology – FDA Cmte.
Executive Summary
FDA should consider using composite markers instead of liver histology as the primary endpoint for hepatitis B trials, members of FDA's Antiviral Drug Products Advisory Committee suggested
You may also be interested in...
Gilead Adefovir Patients Should Be Monitored Every Four Weeks - FDA Cmte.
Gilead's adefovir dipivoxil patients should be monitored every four to eight weeks following initial dosing, FDA's Antiviral Drug Products Advisory Committee recommended during its Aug. 6 meeting
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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