U.S. FDA Probes Devices For Possible Contaminated Heparin
This article was originally published in PharmAsia News
U.S. FDA says it has received 97 reports, 11 of them of deaths, so far this year of adverse events that may have involved devices such as oxygenators and flush solutions containing heparin. The agency said it has not been able to determine the cause of the events and or whether contaminated heparin, such as the Chinese batch linked to 81 other deaths, were contained in the devices. The only two cases traced by the FDA so far showed the heparin was not contaminated, an agency spokeswoman said. (Click here for more - a subscription may be required
You may also be interested in...
A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.
The US HHS played defense on 20 September, pushing back on suggestions that secretary Alex Azar’s recent move to exert control over regulations by signing off on them was a power play aimed at the FDA. Meanwhile, former agency head Scott Gottlieb says it’s “the wrong move at the wrong time.”
With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?