FDA subject matter experts highlight why immunogenicity is important to consider for drug development, discuss the draft guidance for industry “Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling - Content and Format (February 2022)” and creation of the new dedicated subsection 12.6 for immunogenicity information in the labeling.
6:31 - Daphne Guinn
19:55 - Eric Brodsky
Presenters:
Daphne Guinn, Ph.D.
Regulatory Health Project Manager
Office of Clinical Pharmacology (OCP)
Office of Translational Science (OTS) | CDER | FDA
Eric Brodsky, M.D.
Associate Director, Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER | FDA
For slides and additional information: www.fda.gov/dr...
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