CSL's Shortcut from Down Under
This article was originally published in RPM Report
Executive SummaryCSL Ltd. is moving its flu vaccine from Australia (Fluvax) through the US regulatory process in the hopes of importing its product for the 2007 season. CSL is getting help on the US development from the National Institutes of Allergy and Infectious Diseases. The Australian firm may match Glaxo's fast approval for Fluarix in 2005.
You may also be interested in...
FDA is joining the government’s bioresponse and defense efforts to develop small, mobile, on-demand manufacturing systems as next-tech solutions to dwindling domestic supply sources for essential drugs.
How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.
The use of patent “march-in” rights as a tool to control the price of drugs developed with US federal funding support remains substantially less popular with the government-funded research community than with politicians.