Off-Label Use Study Prompts Disagreement On Both Problem And Solution
Executive Summary
Mandatory postmarketing surveillance is needed to address off-label prescribing that is unsupported by evidence, authors of an Agency for Healthcare Research & Quality-funded study say
You may also be interested in...
Rx Comparative Studies Will Be Funded By Neurontin Settlement
The Pfizer Neurontin off-label promotion settlement will fund $28 mil. in comparative efficacy studies for prescription drug products
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