Food And Drug Administration Expert Witness Listings

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David B Ross, MD, PhD, MBI

Clarksville, Maryland
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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Nancy J. Chew, M.S., RAC, FRAPS Regulatory Affairs, North America, Inc.

Durham, North Carolina
Pharmaceutical Regulation Expert Witness - FDA, Food and Drug Administration, 21 U.S.C. and 21 CFR, Investigational New Drug Applications, New Drug Applications, FDA-regulated product development and registration, regulatory affairs practice, FDA regulated industry, submissions/dossiers, labeling, compliance.
Specialty Focus: FDA regulatory requirements, Product development strategy, FDA-regulated product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (CTDs, NDAs), FDA approvals, US agent for FDA matters. Education: M.S. Physiology, Florida State University, 1968. B.A. Biology, Woman's College of the University of North Carolina, 1963. Years in Practice: 35+ Additional Information  Certified regulatory affairs expert with over 35 years experience in pharmaceutical regulatory affairs.  Significant teaching experience in the pharmaceutical and regulatory field, and lectures frequently on regulatory matters.  Published in technical journals, magazines, books, articles, and columns in the regulatory and pharmaceutical fields.  Member of the Scientific Advisory Board for BioLink Sciences, Inc.  Holds a regulatory affairs certification and is a fellow of the Regulatory Affairs Professiona...
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