GLAXO WELLCOME ULTIVA APPROVAL JULY 12 FOLLOWS 10-MONTH "INTERACTIVE" FDA REVIEW OF OPIOID ANALGESIC; EDUCATION PROGRAM TO BEGIN IN MID-SEPTEMBER
Executive Summary
FDA's approval of Glaxo Wellcome's Ultiva (remifentanil) analgesic opioid was based on an "interactive" NDA review process that involved the use of data summaries for the primary review.
You may also be interested in...
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth