EXPERT WITNESS SPECIALTY INDEX
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Pharmacology & FDA Drug Safety Expert Witness | Arizona
This expert is a pharmacist and a pharmacologist and a former professor at Yale University and Georgetown University. He is also a former FDA Medical Officer/Senior Medical Analyst, who is an expert in the areas of drug Safety, drug development, regulatory affairs and FDA policy. He as also served as an advisor on the 2016 Ted Cruz presidential campaign, and has also been invited to testify in...
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Pharmacology Expert Witness | California
This highly qualified expert earned his Bachelor's degree in Chemistry from the University of California Riverside and his PhD in Comparative Pharmacology and Toxicology from the University of California San Francisco. A member of numerous pharmaceutical societies, he is extremely well published, having authored 120+ peer-reviewed papers and 10 books. He previously served as an Assistant...
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FDA Regulations Expert Witness | Connecticut
This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and...
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FDA Regulatory Affairs Expert Witness | Maryland
A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal...
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FDA Regulation and Compliance Expert Witness | Colorado
This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of...
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Pharmacology & Drug Development Expert Witness | Arizona
This highly qualified expert earned his BS from George Fox University and PhD from University of California- Los Angeles. He completed a postdoctoral fellowship at The Scripps Research Institute. He is actively involved in research and education; to date he has 60+ original peer reviewed articles/ abstracts. Currently, he is an Assistant Professor of Pharmacology at a major university affiliated...
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Pharmaceuticals Expert Witness | Virginia
This extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise...
Pharmacology & Toxicology Expert Witness | Ohio
This clinical development and regulatory expert has an M.S and Ph.D. in Pharmacology & Toxicology from West Virginia University. A member of the American Society of Clinical Pharmacology & Therapeutics, he has extensive product development experience in the pharmaceutical field. The expert spent his early career in clinical research roles, including a position as the Director of Clinical Research...
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FDA Expert Witness | Texas
This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality...
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Forensic Chemistry & Substance Analysis Expert Witness | Indiana
This highly-qualified expert has nearly 20 years of experience in the field of forensic chemistry, with his work focusing on the analysis of alcohol, tobacco, controlled substances, and trace evidence such as fire debris, explosives, fibers, paint, and glass. He received his BA in chemistry from Gustavus Adolphus College before earning both his MS in criminal justice and his PhD in analytical...
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Chemistry Expert Witness | New York
This highly qualified expert is located in New York. He received his BS in organic chemistry from The University of Virginia and his PhD in inorganic chemistry from Indiana University. He is an active member in his field with numerous publications and several presentations. He is a member of multiple organizations, including, the American Chemical Society, the Union of Concerned Scientists and...
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May 27, 2020
In early April 2020, the FDA issued a
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