FDA Expert Witness Listings

Welcome to our FDA experts directory. Browse the profiles below to find the right expert witness in FDA for your case. Our SEAK Expert Witness Database is always free to search.

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Christopher M Daft, PhD River Sonic Solutions, LLC

San Francisco, California
Intellectual Property Expert Witness, Medical Devices Expert Witness - Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, DFSS, Regulatory, Integrated Circuit, Semiconductors, Biometric security, Ablation, Tomography, Parallel Computing, Minimally Invasive Surgical Guidance, Wearable Medical Device, Product Liability
Award winning, Oxford Educated scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing and image processing. Dr Daft has deposition and trial testimony experience. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 22 U.S. Patents with several pending. Completed more than 84 hours of SEAK Expert Witness Seminars, including patent-specific training. Diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung and Siemens as well as several start-ups. Well published. Winner of grants from National Institute of Health. Extensive international consulting experience. IEEE (Institute of Electrical and Electronic Engineers) Senior Member since 2004. Three years’ experience teaching electrical and computer engineering at the University of Illinois. Holds BA and MA in Physi...
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John B. Slate, PhD Slate Engineering

Encinitas, California
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Medical Instrumentation, Product Development, Safety, Risk Management, Patents, FDA, Quality Systems, Infusion Pumps, Injection Devices, Dry Eye Treatment Devices, Embedded Control Systems, Sensors
Over 35 years of experience developing medical devices for use in hospitals, clinics, and home care. Dr Slate has held senior management positions leading teams from product conception through manufacturing including conducting clinical studies, obtaining safety certifications, and preparing FDA submissions. A technical contributor skilled in the design of electromechanical systems and embedded controllers, he is an inventor on 24 issued U.S. patents, which are primarily in the field of infusion pumps and injectors for self-administration of insulin and other medications stored in prefilled containers. Experienced in complying with FDA regulations for Quality Management Systems including design control activities such as documenting product requirements, developing the risk management file, and conducting product verification and validation testing.
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Catherine E Patterson, PhD Biotech Research Group (BRG)

Tampa, Florida
Warnings & Labels Expert Witness, Pharmaceutical Regulation Expert Witness - Pharmaceutical, Drug, Device, Failure to Warn, Labeling, FDA, Regulatory, Product Liability, OTC, Prescription, Safety, Risk
Dr. Patterson has focused on human disease and treatments with attention to both efficacy and safety. Investigations of medical literature, legal files and regulatory documents for medical conditions, drug products and medical devices as well as comparators are the basis of her regulatory opinions. Any pharmacovigilance, device safety reviews, adverse event and labeling analyses use resources such as PubMED, Embase, FAERS, MAUDE, and internal company documents. Her regulatory experience has included 510(k), PMA, pre-IND, IND, NDA, ANDA and 505(b)(2) submissions. Dr. Patterson routinely writes FDA submissions, white papers, clinical study protocols, medical descriptions and labeling. She has additional experience with peer-review publications and grant writing. She is currently the Chief Scientific Officer for Biotech Research Group in Tampa. Her PhD was awarded from Princeton University in Molecular Biology for her work with viruses. In the past she provided scientific re...
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J. Lawrence Stevens, RAC ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts

East Alton, Illinois
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints, FDA Inspections
A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, a ...
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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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Joshua Sharlin, PhD Sharlin Consulting

Stevensville, Maryland
Medical Devices Expert Witness, Pharmaceutical Regulation Expert Witness - FDA, FDA Compliance, FDA Regulations, FDA Software, FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device Safety, Hip Implant Safety/FDA, Medical Device Safety/FDA, Drug Safety/FDA, Labels/FDA, Biologics Safety FDA, Implant Safety/FDA, 510(k)/FDA, NDA/FDA, IND/FDA
Have provided Food and Drug Administration (FDA)-related regulatory support to attorneys in cases involving; (i) death or injury caused by drugs, biologics or medical devices, (ii) patents, (iii) insurance claims, (iv) wrongful termination, (v) trade secrets, (vi) merger and acquisitions. Expert in data integrity and software development. Talented in testimony and depositions. Hands-on experience in the entire lifecycle of FDA-regulated product development, from developing an initial regulatory strategy, thru data collection and analysis, to review and approval at FDA. Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. 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? (Se...
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Ann Prewett, PhD

Bloomfield, Michigan
Medical Devices Expert Witness, Products Liability Expert Witness - product development, bone graft, orthopedic, vascular grafts, collagen, biomaterials, FMEA, FDA, CE Mark, Design Control, ISO13485, CAPA, biocompatibility testing, spine product, spine fusion, chemical analysis, polymer characterization, sterilization, ethylene oxide, wear debris, FMEA, 510k
PhD in Chemistry, with 28 years experience in medical device field. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am a named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial leading to successful outcomes in major intellectual property patent cases. Am well-spoken and articulate and can provide convincing and credible testimony. I have authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Creative problem solver that can contribute to strategic thinking and approach in legal cases. Key talent is analyzing scientific data and finding strengths or weaknesses in the methods, data and scientific approach. Strong testifier, not easily caught off guard. Have worked in all areas of product development from conception, design, design validation, design transfer, production and comm...
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Ann Prewett, PhD

New Jersey
Medical Devices Expert Witness, Products Liability Expert Witness - product development, bone graft, orthopedic, vascular grafts, collagen, biomaterials, FMEA, FDA, CE Mark, Design Control, ISO13485, CAPA, biocompatibility testing, spine product, spine fusion, chemical analysis, polymer characterization, sterilization, ethylene oxide, wear debris, FMEA, 510k
PhD in Chemistry, with 28 years experience in medical device field. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am a named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial leading to successful outcomes in major intellectual property patent cases. Am well-spoken and articulate and can provide convincing and credible testimony. I have authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Creative problem solver that can contribute to strategic thinking and approach in legal cases. Key talent is analyzing scientific data and finding strengths or weaknesses in the methods, data and scientific approach. Strong testifier, not easily caught off guard. Have worked in all areas of product development from conception, design, design validation, design transfer, production and comm...
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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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