FDA Oncologic Cmte. More Wary About Recommending Accelerated Approval
Executive Summary
FDA's Oncologic Drugs Advisory Committee could be more wary of recommending accelerated approval for anti-cancer agents based on limited clinical data
You may also be interested in...
Oncologic Confirmatory Trial Failure Not Fatal To Accelerated Approval – FDA
Cancer drugs with failed confirmatory trials may still receive accelerated approval, FDA suggested during the Oncology Drugs Advisory Committee May 12
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