FDA Refines Guidance On Immunogenicity Testing
FDA’s final guidance on the development of assays used in clinical trials to evaluate the immunogenicity of therapeutic proteins provides more detail on where immunogenicity information is to be placed in BLAs, and adds appendix on a multi-tiered approach to anti-drug antibody testing.
You may also be interested in...
While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.
The WHO proposes to revise 2011 guidance on technology transfers to ease the hand-off of COVID-19 drugs and vaccines from research and development facilities to commercial sites.
Two groups have issued largely complementary testing methods for measuring nitrosamine impurities in drugs, and the differences that do exist are “insignificant,” EDQM official advises. The two are working to further harmonize testing standards, given the global scope of the nitrosamine scare.