FDA Refines Guidance On Immunogenicity Testing
Executive Summary
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...
Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
EU GMP Annex I Is A Top Priority For EMA While Industry Has Lingering Concerns
Questions about contamination control strategy raised as European Medicines Agency makes EU GMP Annex I revision a top priority in its 2021 work plan.
US FDA Mulls Advance Notice On Domestic Surveillance Inspections Post-COVID
Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.