Pharmacogenomics Development Incentives Will Be Outlined By FDA
Executive Summary
FDA will publish a document this year on the applicability of pharmacogenomics to existing drug development incentives to encourage sponsors to submit genomic data
You may also be interested in...
Pharmacogenomics Guidance Cites Benefits Of Voluntary Submissions
FDA's final pharmacogenomics guidance outlines the benefits of voluntary pharmaceutical industry submissions of genomic data to the agency
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