David B Ross, MD, PhD, MBI Expert Witness
Curriculum Vitae

Contact Information

  • Phone: 301 500 8557
  • Cell: 301 500 8557
  • Fax: 443 703 7754
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Specialties & Experience

General Specialties: Pharmaceutical Regulation and Infectious Diseases

Specialty Focus: Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile

Education: MD, New York University School of Medicine; PhD, New York University Graduate School of Arts and Sciences; MBI, Masters in Biomedical Informatics, Oregon Health and Sciences University; Board Certified, Infectious Diseases, American Board of Internal Medicine

Years in Practice: 25+

Number of Times Deposed/Testified in Last 4 Yrs: 14


Additional Information

Dr. Ross is a Yale fellowship-trained, board-certified infectious disease physician. An active clinician in practice for over 25 years, he provides patient care in the areas of infectious disease and primary care. Dr. Ross holds a medical degree from New York University School of Medicine, and an undergraduate degree in Molecular Biophysics and Biochemistry from Yale University. 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 and Sciences University. Dr. Ross spent 10 years with 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 is a frequently invited presenter at medical conferences, industry meetings, medical societies, and hospital grand rounds. Dr. Ross is an experienced expert witness at the federal and state levels. 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.