NeutroSpec Withdrawn For Safety Reasons Shortly After “Dear Doctor” Letter
Executive Summary
FDA requested the market withdrawal of Palatin/Mallinckrodt's NeutroSpec less than three weeks after the companies issued a "Dear Healthcare Provider" letter addressing potential safety concerns with the imaging agent
You may also be interested in...
Tysabri Withdrawn Pending Analysis Of Safety Signal In Long-Term Trial
Biogen Idec and Elan are convening a panel of experts on progressive multifocal leukoencephalopathy as the first step towards reintroducing the multiple sclerosis therapy Tysabri (natalizumab)
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