Quick-fire interview on immunogenicity with Mohsen Rajabi (FDA)

My name is Mohsen Rajabi. I am a Pharmacologist in the Division of New Drug Bioequivalence Evaluation (DNDBE), Office of Study Integrity and Surveillance, Office Translational Science, Center for Drug Evaluation and Research, US FDA. I conduct study-directed and comprehensive surveillance inspections of firms that conduct pharmacokinetic and bioavailability/bioequivalence (BA/BE) studies submitted to the FDA. What do you think are the main challenges you face in your role? To detect data integrity and to be able to verify the accuracy and completeness of data generated to meet applicable regulatory requirements. What is your favorite aspect of your work? Traveling and learning...