David Doleski

  PhotoJ. David Doleski is the Acting Director of the Division of Good Manufacturing Practice Assessment in the Office of Compliance, Center for Drug Evaluation and Research (CDER), FDA. In this position, he directs program activities involving pre-approval inspections, review of inspection recommendations, and determination of manufacturing site acceptability. He has been employed by FDA since 1990, including various positions of increasing responsibility with respect to the review and inspection of biologic and drug products.