Manufacturers Should Oversee CROs, Investigators – U.S. Prosecutor Sheehan
Executive Summary
Pharmaceutical manufacturers will be held liable for the conduct of contract research organizations and principal investigators, Assistant U.S. Attorney Jim Sheehan said
You may also be interested in...
FDA Re-evaluating Drug Data Generated By Fraudulent Clinical Investigator
FDA is reviewing data related to drug studies conducted by clinical investigator Robert Fiddes, MD, to ensure the safety and effectiveness of products for which he falsified clinical trial data.
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