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

Contact Information

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Specialties & Experience

General Specialties: Pharmaceutical Regulation

Specialty Focus: Food and Drug Administration,Drug/Biologics Safety,Drug/Biologics Adverse Events,Drug/Biologics Labeling,Post-marketing Surveillance,Clinical Trials,FDA Regulations/Procedures,Investigational New Drug Applications(IND),New Drug Applications(NDA),Biologics Licensing Applications(BLA),GMPs,Compliance

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, Internal Medicine Infectious Diseases, American Board of Internal Medicine

Years in Practice: 25

Number of Times Deposed/Testified in Last 4 Yrs: 8

Additional Information

I provide consulting services on legal issues in drug safety and efficacy. Specific focus areas include examining the adequacy of product labeling to inform health care providers and patients about the benefits and risks of drugs, biologics, and other FDA-regulated products, as well as the accuracy and completeness of information provided by pharmaceutical manufacturers to investors and securities regulators. My experience includes provision of expert input and support for research into the merits of an action, drafting of court filings, preparation of responses to opposing party filings, and conducting discovery. I have experience in preparing expert witness reports, depositions, and trial testimony. My professional background includes serving for 10 years with the FDA’s Center of Drug Evaluation and Review as a medical officer, senior medical reviewer, medical team leader, and drug review office management official. ➢ Ten years (1996-2006) at FDA Center for Drug Evaluation and Research (CDER) as medical reviewer, team leader, associate office director (oncology), and deputy office director (biologics) ➢ Broad experience with regulatory submissions (INDs, NDAs, BLAs, post-marketing safety, labeling supplements) for both small molecules and biologics ➢ Extensive familiarity with FDA regulations and procedures, including drug/biologic labeling and compliance requirements ➢ Expert witness experience includes drug safety cases, civil securities fraud, patent infringement, pharmacy compounding, and drug adulteration and contamination ➢ Active clinician (infectious diseases, primary care/general internal medicine)