CSL's RiaSTAP approved in US for fibrinogen deficiency
This article was originally published in Scrip
Executive Summary
The US FDA has granted accelerated approval of CSL Behring's clotting agent RiaSTAP (fibrinogen concentrate (human)) for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, an orphan indication that affects 150-300 people in the US.
You may also be interested in...
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations
US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.
US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects
CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.