We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA: NDA Sponsors Should Include Data From Immunogenicity Testing
FDA: NDA Sponsors Should Include Data From Immunogenicity Testing
December 9, 2009
Sponsors submitting new drug applications (NDAs) should include data supporting the full validation of assays related to immunogenicity testing, which gauges the risk of patients developing a harmful immune response to therapeutic proteins, a draft FDA guidance says.