Pharmaceutical Regulation Expert Witnesses in Maryland

Pharmaceutical Regulation, Infectious Diseases - 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

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 ...

Pharmaceutical Regulation, Medical Devices - FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times. Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries. Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it? Provide FDA related ...