Michael Kopcha

Director, Office of Pharmaceutical Quality, FDA

Michael Kopcha, Ph.D., R.Ph. is the Director of the FDA’s Office of Pharmaceutical Quality (OPQ). This office has over 1,300 staff responsible for assuring the availability of quality medicines for the American public through assessment, inspection, surveillance, research, and policy. OPQ contributes to the assessment of nearly every type of human drug marketing application including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), including 351(k) applications (i.e., biosimilars). OPQ also performs the quality assessment of Investigational New Drug Applications (INDs) and establishes quality standards for over-the-counter drug products and facilities.

Prior to joining the FDA, Dr. Kopcha amassed more than 25 years of experience in major and mid-sized innovator, generic, drug/device, and over-the counter (OTC) pharmaceutical and consumer health companies. He developed expertise in areas including formulation and process development, product scale-up, process validation, technology transfer, project management, change management, and off-shoring/outsourcing. Dr. Kopcha most recently served as Vice President, and global research and development franchise head, for cough, cold, and respiratory products at Novartis Consumer Health, Inc.

Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science, and a bachelor’s degree in pharmacy from Rutgers University. He also served as an adjunct assistant professor in the Department of Pharmaceutics at Ernest Mario School of Pharmacy at Rutgers.