David B Ross, MD, PhD, MBI
Pharmaceutical Regulation Expert Witness
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
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 a...
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