US FDA panel to review bleeding, thrombosis products
This article was originally published in Scrip
Executive Summary
TheUS FDA's blood products advisory panel willmeet on January 9th to discussCSL Behring's BLA for plasma-derived fibrinogen concentrate for the treatment of bleeding in patients with congenital fibrinogen deficiency. Later the same day the experts will discuss GTC Biotherapeutics' BLA for ATryn (recombinant antithrombin III) for patients with hereditary antithrombin deficiency to prevent thrombosis during high-risk surgical and obstetrical procedures. ATryn is produced from the milk of transgenic goats. Ovation Pharmaceuticalslicensed the US rights from GTC in August. The product has orphan status and is undergoing a priority review, with a February user fee date.
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.