Jessica G. Chiaruttini FDA

As a Senior Microbiology Reviewer in FDA’s Center for Drug Evaluation and Research Division of Microbiology Assessment, Jessica Chiaruttini is responsible for the review of Investigational New Drug Applications (INDs), New and Abbreviated Drug Applications (NDA/ANDAs), and combination drug products.  Dr. Chiaruttini has extensive experience with regulation of novel manufacturing platforms and test methods, as well as traditional aseptic and terminal sterilization procedures, and control of non-sterile drug products.  She routinely consults to CDER’s Office of Compliance on microbiology-related inspectional and contamination events in the industry.  She obtained a BS in Microbiology from the University of Georgia and a PhD in Emerging Infectious Diseases at the Uniformed Services University of the Health Sciences.  Other work experience includes collaboration with Mozambique’s Ministry of Health and CDC to expand HIV viral load testing capacity and clinical microbiology testing at the CDC’s National Reference Laboratory for Escherichia coli and Shigella.  Dr. Chiaruttini holds the rank of Commander in the United States Public Health Service Commissioned Corps and has nine years of commissioned service.