Infectious Disease Physician & Former FDA Reviewer

Specialties & Experience of this Expert Witness

Additional Information

Dr. Ross is a Yale fellowship-trained, board-certified infectious disease physician with expertise in clinical medicine, pharmaceutical development and regulation, and public health . An active clinician in practice for over 30 years, he provides patient care in the areas of infectious disease and primary care. Dr. Ross received his undergraduate degree in Molecular Biophysics and Biochemistry from Yale University and his medical degree from New York University School of Medicine. He completed his internal medicine residency training at NYU Medical Center and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health & Sciences University. Dr. Ross spent 10 years at the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely broad experience with FDA regulatory submissions (INDs, NDAs, BLAs, post-marketing safety, labeling supplements) for both small molecules and biologics. He has extensive familiarity with FDA regulations, processes, and procedures, including drug/biologic labeling and compliance requirements. Dr. Ross was the recipient of CDER’s Excellence in Communication and Excellence in Leadership Awards. Dr. Ross has published extensively in book chapters and medical articles. He has presented frequently at medical conferences, industry meetings, medical society meetings, and hospital grand rounds. Dr. Ross has served as an expert witness in litigation in Federal and state courts, as well as in arbitration proceedings. Dr. Ross has been called upon to express opinions in the areas of medical malpractice, personal injury, negligence, standard of care, and product liability. He has also provided testifying and non-testifying expert witness services in cases involving drug safety, civil securities fraud, patent infringement, pharmacy compounding, and drug adulteration and contamination.