Device immunotoxicity testing procedures outlined in FDA draft guidance.
This article was originally published in The Gray Sheet
Executive Summary
DEVICE IMMUNOTOXICITY TEST DATA REQUIRED for potentially immunotoxic devices that do not have data in the public domain supporting their non-toxicity, FDA says in a "Draft Immunotoxicity Testing Framework" released Oct. 21.
You may also be interested in...
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.
Could Eledon’s Anti-CD40L Change Transplant Medicine?
Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it for pig-to-human kidney and heart transplants, opening up the field of xenotransplantation.
Turning That Frown Upside Down: Treating Depression With Facial Botox Injections
In this episode of the In Vivo podcast, Eric Finzi, CEO of Healis Therapeutics, discusses how his company is targeting major depression, post-traumatic stress disorder and other mental illnesses using facial botox injections.