Arifa Khan PhD U.S. FDA

Dr. Arifa S. Khan is a Supervisory Microbiologist and Head of the Molecular Retrovirology Unit in the Division of Viral Products, Office of Vaccines Research and Review, CBER/FDA. She moved from NIAD/NIH to CBER in 1991 and established a research program focused on cell substrate and vaccine safety. Dr. Khan is currently leading efforts on high-throughput sequencing for the detection of adventitious viruses and endogenous retroviruses for the safety of biologics. Her primary regulatory responsibilities include viral vaccines, such as HIV-1, influenza virus, RSV, and SARS-COV-2. Dr. Khan also provides expert consultation on viral safety and testing to OTAT/CBER and CDER. She has been involved in the licensure of several viral vaccines and contributed to the development of various FDA and international documents related to viral safety. She is currently the FDA Deputy Topic Lead in the Implementation Working Group for the ICH Q5A(R2) and on the Working Party for the new European Pharmacopeia chapter on high-throughput sequencing. Dr. Khan obtained her Ph.D. in Microbiology from George Washington University, Washington, D.C. She has authored more than 100 publications.