Cancer Prevention Drugs Require Protocol Assessment Before Phase III – FDA
All oncologic risk reduction drugs should have a special protocol assessment (SPA) before entering Phase III trials, FDA advises staff in a recently issued "Manual of Policies and Procedures" guidance
You may also be interested in...
Deputy director of FDA's biological oncology product review team Robert Justice will head the Division of Drug Oncology Products under the reorganization of the Office of New Drugs
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