FDA issues guidance on immunotoxicity testing:
This article was originally published in Clinica
The US FDA has issued draft guidance on immunotoxicity testing. It is designed to provide reviewers and manufacturers with a coherent strategy for assessing whether testing for potential adverse effects involving medical devices or constituent materials and the immune system is needed. Comments to the draft are required by June 16th. For further details, contact John Langone at the CDRH on +1 (301) 443 7132.