FDA Expert Witnesses
Fda expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on fda. The fda expert witness listings on this page are typically from fields/areas of expertise such as: Artificial Intelligence, Biomedical Engineering, Chemistry & Chemicals, Food, Health Informatics, Hotel & Restaurant, Infectious Diseases, Intellectual Property, Manufacturing, Medical Devices, Oncology, Pharmaceutical Regulation, Pharmaceutical Research, Products Liability, and Statistics.
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Denise S. Holliday
Medical Device Quality and FDA Regulatory Expert
Capwell Consulting Group LLC
Medical Devices, Biomedical Engineering
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Ophthalmology, Spinal Implants, Non-Active Implants, Cardiology, Ventilators, General Hospital, Orthopedic, Gynecology/Obstetrics, General Surgical Equipment, In-Vitro Diagnostics, Dental, Software, Neurology, Prosthetics, Sterilization, 483 Warning Letters, FDA Regulatory Compliance, FDA Approvals
Denise Holliday is a proven strategic innovator and tactical leader in highly regulated environments, including quality management systems, international regulatory compliance, and medical device risk management. As a leading medical device regulatory consultant for Capwell Consulting Group, she provides strategic support to medical technology businesses, healthcare organizations, and startups. She delivers expert testimony for medical device litigation, guiding attorneys and organizations through the complexities of the global medical device industry. Manufacturers and attorneys trust Ms. Holliday to help navigate the complex regulatory landscape of medical device manufacturing and ensure compliance with standards and guidelines.
Spanning almost two decades, Ms. Holliday’s career in medical device regulatory compliance and quality assurance showcases her extensive leadership experience. She conducts ISO 13485Medical Device and ISO 9001Quality Management certification audits, spear...
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Christopher M Daft, PhD
Patents, Trade Secrets and Medical Devices
River Sonic Solutions, LLC
San Francisco, California
Intellectual Property, Medical Devices
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Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, Neuromodulation, Regulatory, Integrated Circuit, Semiconductors, Biometric Security, Wearable Biometrics, Tomography, Neural Networks, Artificial Intelligence, 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.
- 5 trial testimonies and 15 depositions.
- Litigation experience includes district court, ITC and PTAB matters.
- Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation.
- Serial inventor holding 27 U.S. Patents with 20 applications pending.
- 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 and DARPA.
- 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 Physics from...
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Timothy A Anderson
Chemistry and Manufacturing Controls (CMC), FDA
The AquaMarine Group, Inc.
Redding, Connecticut
Pharmaceutical Regulation, Manufacturing
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Current Good Manufacturing Practice, ANDA, cGMP, CMC, Active Pharmaceutical Ingredient, Food and Drug Administration, 505(b)(2), NDA, New Drug Application, NCE, Regulatory compliance, BLA, Drug Master File, Method validation, CRL, Due diligence, FDA, Chemistry and Manufacturing Controls, API, label
Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely inter-disciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.
As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors.
Mr. Anderson has contributed to...
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J. Lawrence Stevens, RAC
FDA Medical Device Expert
ONE WAY CONSULTANTS. LLC, FDA Regulatory Experts
East Alton, Illinois
Medical Devices, Biomedical Engineering
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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
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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Joshua Sharlin, PhD
SHARLIN CONSULTING
STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices
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FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability
Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times.
Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries.
Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions.
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?
Provide FDA related ...
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Gary Fischman, PhD, FACerS, FNICE
Materials Science - medical and dental ceramics
Future Strategy Solutions
Gambrills, Maryland
Medical Devices, Products Liability
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ceramics, Dental Ceramics, Dental zirconia, hard materials, coatings, device failures, medical ceramics, zirconia, medical device standards, properties of materials, FDA, IP, Patents, Manufacturing and Processing
Gary Fischman is the principal and owner of Future Strategies Solutions LLC. He is a domain specialist in hard materials, specifically ceramics and hard coatings. He has done legal expert work in issues in medical and dental ceramics.
Dr. Fischman has worked with discovery, written expert reports, been deposed and testified as an expert witness.
Formerly, a tenured faculty member at the New York State College of Ceramics at Alfred University, Dr. Fischman worked in processing hard, strong materials that ranged from non-oxide semiconductors to oxide ceramics for biomedical applications. During the early years of biomedical applications of materials, Dr. Fischman was front and center developing classes, doing research specifically in hard material (non-oxides) as well as medical oxides (aluminas and zirconias). During that time, he teamed with a colleague and created a small business that made ceramics for biomedical applicationsn (Xylon Ceramic Materials).
Dr. Fischman then tr...
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Anwar Ouassini
Harvard AI Expert: Healthcare, LLMs, Agentic AI
Cambridge, Massachusetts
Artificial Intelligence, Health Informatics
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Healthcare AI, Bad Faith Denials, Insurance Denials, HIPAA, Machine Learning, Prior Authorization, Agentic AI, Clinical Decision Support, FDA, RAG, LLM Hallucinations, Generative AI, Utilization Review, EEOC, AI Ethics, Algorithmic Bias, AI Governance, AI Fraud, Daubert, ChatGPT
AI expert witness with 15+ years building, deploying, and auditing 100+ production AI systems. Rare combination of practitioner, scholar, and researcher - the expert opposing counsel can't dismiss as "just an academic" or "just an engineer." Most AI experts fall into one category: academics who've never shipped production code, or engineers who can't write a defensible report. I've done both - built AI systems at Harvard Medical School, Apple, and federal agencies while publishing award-winning peer-reviewed research on AI ethics and large language models. This dual foundation creates opinions that survive Daubert challenges and cross-examination.
Technical expertise spans multiple domains, including healthcare AI and insurance bad faith litigation, including prior authorization algorithms, utilization management systems, AI-driven claim denials, and clinical decision support failures. Deep experience with LLM hallucinations and defective outputs including GPT, Claude, and Llama fa...
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Debra Leibold, MD, PhD
Consultant
Blue Bell, Pennsylvania
Pharmaceutical Regulation, Warnings & Labels
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Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use
Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J:
Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products.
Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World.
Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?”
Provide leadership in support of label development for new applications, supplemental appl...
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Lei Li
PhD Biostatistician & FDA Clinical Trial Expert
LunarAI LLC
Landenberg, Pennsylvania
Statistics, Medical Devices
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biostatistics, FDA, Pharmaceutical Statistics, Sanofi, Edwards, Gilead, AI/ML expert, machine learning, clinical trial, Medical Device, Vaccine, Group Sequential Design, Bayesian Adaptive Design, Statistical Review of Evidence, Oncology, Epidemiological, Regulatory Submissions, Survival Analysis, Statistical Expert Witness, RWE
Lei Li, PhD, is a biostatistician, statistical expert consultant, and former FDA/CDRH statistical reviewer with extensive experience in regulatory statistics, real-world evidence (RWE), medical device submissions, pharmaceutical development, clinical trials, and quantitative model evaluation. He is currently supporting two active expert consulting matters involving statistical evidence review, regulatory and clinical data interpretation, assessment of quantitative methods, and evaluation of model assumptions, uncertainty, and data reliability.
At FDA/CDRH, Dr. Li evaluated statistical components of 510(k), PMA, and other medical device submissions; assessed safety and effectiveness evidence; reviewed RWE and post-market studies; and advised on complex statistical issues for regulatory decision-making. His FDA work included evaluation of study design adequacy, endpoint justification, sample-size rationale, bias and confounding, missing data robustness, and interpretation of clinical...
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ALEJANDRO ECHEVERRY, Ph.D.
Texas Tech University
LUBBOCK, Texas
Food, Hotel & Restaurant
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Food Safety Microbiology, Restaurant Food Poisoning, Food Intoxication, Foodborne illness, FDA, USDA, Quality Assurance, Hygienic Design, Food Engineering, Food Service, HACCP / SSOP / Operating Procedures, GMP General Manufacturing Practices, Foreign Material, Bacterial Pathogen, Food Contamination, Contamination, FSMA, FSIS, CCP
I’m an Associate Professor of Practice in Food Safety and Food Engineering at Texas Tech University, where I’ve been developing and teaching undergraduate and graduate level classes in the areas of food microbiology, food safety, food engineering, and hygienic design of food processing plants since 2008. I’ve had the opportunity to become familiar with different food matrixes and processes including Beef, pork, poultry, RTE meats and possess extensive knowledge of USDA-FSIS and FDA regulations and requirements for the production of safe food products. Moreover, since 2013 I have provided consulting services to food industry companies and/or law firms on several topics related to food science, safety, shelf life, HACCP, process control, microbiology, SSOPs, food production or providing and conducting studies to validate the safety of the processes conducted and to train personnel on food safety practices, including handling, storage, temperature control, safety practices, cooking/l...
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Frederick H Hausheer, MD, FACP
Oncology Drug R & D, ICH GCP, Drug Patent Validity
HAUSHEER BIOMED, LLC USA
Austin, Texas
Oncology, Pharmaceutical Regulation
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Oncology Drug Development, Patent Validity, ICH GCP, Written description, Enablement, Obviousness, Anticipation, Pharmacology, FDA, EMA, NMPA/China, PMDA/Japan, Drug formulation, Medical Safety, Phase 1-3 Clinical Trials, Drug Product Safety, Medical Oncology, Breach of Contract - Pharma/Biotech, Commercially Reasonable Efforts, Damages
Dr. Frederick (Fred) Hausheer is a physician-scientist with over 37 years of executive leadership and management experience in US and international (EU, JP, China, others) commercial pharmaceutical research and development (Phase I-III), preclinical translational and clinical medicine, clinical pharmacology, ICH GCP compliance and commercial development strategy and risk management of novel cancer therapeutics. His commercial research and development experience includes cytotoxic agents, targeted agents, immuno-oncology therapeutics, cell therapies (BMT, CAR-T), and supportive care medicines. He is an inventor/co-inventor on more than 400 issued United States and international pharmaceutical patents, and author/co-author of more than 200 scientific/medical publications.
He is an experienced former CEO and Chief Medical Officer with several biopharma companies and a former NCI-Designated Clinical Investigator, NCI-Institutional Review Board voting member, and NCI-Experimental Ther...
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Ethan Alden-Danforth, PhD
Cosmetic & OTC Expert Witness | PhD Chemist
Shelburne, Vermont
Chemistry & Chemicals, Manufacturing
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Cosmetics, Microbiological Testing, PFAS / Heavy Metals, Adulteration & Misbranded, Contamination, Contract manufacturing, OTC Drug, Product Liability, False Advertising, MoCRA Compliance, Formulation, Claims Substantiation, Cosmetic Labeling, Personal Care Product, Cosmetic Chemistry, Analytical Testing, Adverse Event, Defect, FDA, GMP
My name is Ethan Alden-Danforth and I am a senior executive in the cosmetic and OTC personal care industry with over 15 years of experience in R&D and manufacturing. I hold a PhD in Organic Chemistry from Johns Hopkins University and currently serve as Vice President of R&D for a cosmetic contract manufacturer, where I oversee formulation development, raw material sourcing, product safety and testing, regulatory compliance, and process engineering across cosmetic and OTC drug product lines.
I provide expert witness services for plaintiff and defense counsel in state and federal litigation involving cosmetic and OTC personal care products. My litigation work encompasses product liability and class action matters, false advertising and labeling disputes, FDA and MoCRA compliance failures, PFAS and heavy metals contamination, microbial and chemical adulteration, GMP violations, contract manufacturing disputes, recalls, and adverse event investigations. I have experience reviewing tech...
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Peter Coderre, PhD
FDA Regulatory, Infectious Disease
Antimicrobial Regulatory Consulting
Lovettsville, Virginia
Pharmaceutical Research, Infectious Diseases
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pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, medical microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP
25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science.
Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense.
Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs.
As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...
