FDA Expert Witnesses
What is an FDA expert witness?
FDA expert witness candidates typically have years of experience in healthcare, drug development, food and drug safety, pharmacology, FDA regulations, and/or regulatory affairs. FDA expert witnesses typically hold advanced degrees (MD, PhD, PharmD) and prior experience in FDA compliance. An FDA expert witness should feel comfortable explaining technology, processes, and procedures to a judge and jury. In a high-profile case, or litigation involving a significant financial stake, a law firm may request a subject matter expert with prior expert testimony experience.
What types of cases require an FDA expert witness?
Cases that may require an expert witness with an FDA background will involve drugs, food, medical devices, radiation-emitting products, vaccines, biologics, animal and veterinary products, cosmetics, and/or tobacco products. With FDA compliance and good manufacturing practices (GMP), companies adhere to minimum quality systems requirements to assure that their products are consistently safe and high in quality. The FDA Adverse Event Reporting System Database (AERS or FAERS) tracks drug safety; the database collects adverse effects reports, medication error reports and product quality complaints.
FDA expert witness case examples
Cahn Litigation Services has completed numerous searches for FDA expert witnesses, providing candidates for each case to the specifications provided by the law firm. Exemplary projects include:
- regulatory product labeling and safety information,
- a dietary supplement clinical trial validation,
- hospitalization as a result of a medical device product liability,
- medical device manufacturers’ regulatory submissions,
- cardiovascular implant premarket approval (PMA),
- pharmacovigilance,
- FAERS data mining,
- drug names and drug labels,
- systematic reviews,
- biologic products,
- clinical trial adverse event incidence,
- enzyme inhibitors,
- cosmetic product development methodology,
- safety signal resulting from healthcare professional spontaneous reports,
- adverse drug reactions reporting rate,
- new drug side effects causation and safety concerns,
- post-marketing commitments (PMCs) data source,
- adverse drug event mitigation case report,
- food manufacturing quality assurance, and
- citations related to a pharmaceutical former FDA approval.
What litigation support work might an FDA expert witness be expected to perform?
Litigation support by an FDA expert witness could include research and authoring expert reports, providing expert opinions, depositions, and trial testimony. In addition, clients may seek an FDA expert for pre-litigation consulting work.
Cahn Litigation Services has the experience required to turn a search for an FDA expert witness around quickly, providing the right balance of expertise and testimony experience.
Related Disciplines
FDA Expert Witness - Representative Bios
Please Note: All Cahn Litigation expert witness searches are customized to attorneys' precise specifications and preferences. Attorneys are encouraged to discuss search parameters with a Cahn search specialist.
The below expert witness bios represent a small fraction of those FDA experts known by Cahn Litigation Services. These bios are provided to give lawyers a sense of the FDA landscape.
Expert Witness #254186
This expert is a Director in the FDA Regulatory practice of an internationally recognized consultancy. This expert's areas of expertise include review of promotional materials for products of all types, strategic analysis of regulatory pathways and laboratory developed tests. This expert also advises clients in the areas of informed consent, investigator disqualification proceedings, Form 483/Warning Letter responses, quality agreements, and good manufacturing practices. Additionally, this expert serves as an expert witness on FDA processes. This expert has decades of regulatory strategy and compliance experience in the Life Sciences industry in roles at a federal agency and in private legal practice. This expert is frequently called upon by clients to assist in navigating FDA regulations. This expert became very familiar with the premarket approval processes for all types of therapeutic products regulated by FDA. This expert has advised many manufacturers of regulated therapeutic products on the meaning and application of the Federal Food, Drug, and Cosmetic Act. Furthermore, since enactment of the Family Smoking Prevention and Tobacco Control Act this expert has advised clients who are manufacturers of:
- e-cigarettes,
- hookah, and
- traditional cigarettes
on the meaning and application of the Tobacco Control Act statutory provisions and FDA regulations and guidance documents.
This expert is familiar with FDA's interpretation of "predicate product" and "substantial equivalence" in the context of tobacco products, which is much narrower than the agency's interpretation of the same terms in the context of medical devices. In addition, this expert has advised e-cigarette and hookah clients on whether their products met the definition of a "new tobacco product" requiring the submission of substantial equivalence information to FDA.
Start FDA Expert SearchExpert Witness #247814
This expert is a long-time Food and Drug Administration authority. This expert's current consulting firm is focused on FDA compliance, specifically the CMC (Chemistry, Manufacturing and Controls) section of the FDA submission which governs labeling, and exactly what quantities, purities, strengths and other specifications the applicant is allowed to bring to market. This expert possesses Regulatory, Technical and Management expertise in FDA compliance. This expert also holds two US patents and is well published in the field. This expert has served as an Adjunct Professor.
Start FDA Expert SearchExpert Witness #247822
This expert has acquired a unique expertise in opioid pharmacology and safety. This expert's experience as a former Medical Officer and Senior Medical analyst included literally hundreds of cross-disciplinary team reviews and meetings with pain/neurology experts establishing this expert as a valued pharmacology and drug safety expert. This expert is currently an Associate Professor at a University, and served as an FDA/Healthcare advisor in a presidential campaign. As part of this expert's research duties this expert routinely analyzes drug safety and personally owns and maintains a specialized server which houses an exact copy of the FDA's AERS/ FAERS database. This expert has been quoted dozens of times by major news organizations.
Start FDA Expert SearchExpert Witness #224615
This expert is a Pharmacology Ph.D. This expert's specific specialties are drug advertising, labeling and regulatory affairs, as well as clinical regulatory compliance and trial design. As the Senior Consultant in a firm, this expert provides regulatory and scientific input and strategy to clients planning submission of their biomaterials to the FDA. This expert regularly advises on the preparation and submission of INDs, IDEs, NDAs, PMAs, and PLAs. Previously, this expert was responsible for all clinical and pre-clinical reviews of INDs, NDAs Amendments, Supplements, Orphan Drugs and ANDAs. This expert has over 35 publications and is active in many professional organizations and associations. This expert has written four expert reports, given three depositions, and testified twice at trial.
Start FDA Expert SearchExpert Witness #209803
This expert is an experienced food and drug manufacturing standards expert. This expert set up over 250 Quality systems for compliance and /or certification, audited over 400 pharmaceutical and medical device manufacturers and participated in over 200 FDA audits of regulated companies for devices, food banks and other categories. This expert knows the laboratory environment and understands cleanliness / sterile requirements for the preparation and/or manufacture of food and drug products.
Start FDA Expert SearchExpert Witness #267522
This expert has many years of microbiology experience including practical proficiencies in pharmaceutical, biotech, medical device research and development, manufacturing quality and business development. This expert also brings to the table practical experience as a microbiology expert witness in patent litigation and product liability cases. This expert has successfully served as a microbiology expert witness on numerous cases, representing branded and generic drug companies, corporations and individuals, plaintiffs and defendants. This expert has supported clients during fact finding/expert discovery and claim construction in addition to providing consultation, patent review, expert opinion, deposition and trial testimony. This expert has also provided technical guidance to counsel in preparation of taking depositions.
This expert has significant education, training, skill sets and experience, and has provided legal support as a consultant and expert witness in many areas, including:
- Pharmaceutical microbiology
- Sterility assurance
- Good Manufacturing Practices (GMPs)
- FDA regulatory compliance
- Contamination control
- Sterilization
- Preservative and antimicrobial effectiveness
- Compounding pharmacy microbiology
- United States Pharmacopoeia (USP) testing
- Laboratory operations
- Ophthalmic formulations and contact lens care
This expert’s capabilities span a wide range of applications and functions, including, but not limited to:
- Manufacturing
- Sterility assurance and aseptic processing
- cGMP compliance
- Investigations of microbial excursions, presence of objectionable organisms and out-of specification findings
- Contamination control and bioburden reduction strategies for sterile and non-sterile fill-finish facilities
- Manufacturing isolator and RABS design, cycle development and microbiological validation
- Process development
- Manufacturing facility design and qualification
- Process Analytical Technology (PAT)
- Environmental monitoring (sterile and nonsterile)
- Fermentation, recovery and purification microbiological control (API, bulk drug)
- Process water monitoring and maintenance
- Disinfection and sterilization
- Cleaning validation
- Audit readiness
- Rapid microbiological method (RMM) validation and implementation
- Microbiology Laboratory
- Laboratory audits, optimization and management
- Laboratory design, qualification, optimization and automation
- Sterility test isolator design, cycle development and microbiological validation
- cGMP compliance
- Microbiology method suitability testing, including the harmonized Sterility Test and Microbial Limits Test, Antimicrobial Effectiveness testing, USP 1223 and1227
- Sterility testing (harmonized)
- Antimicrobial and preservative effectiveness testing
- Environmental monitoring
- Pharmaceutical-grade water analysis
- Bioburden and microbiological examination of nonsterile products (harmonized Microbial Limits Test)
- Disinfectant effectiveness validation
- Microbial identification strategies and instrument/method validation, including gene sequencing and MALDI
- Endotoxin analysis and method validation
- SOP and protocol development
- Method validation and technology transfer
- Pharmacopoeia (e.g., USP, Ph. Eur., JP) interpretation and compliance
- Risk assessments (e.g., objectionable organisms, microbial data deviation, bioburden excursions)
- Documentation and data management
- Rapid microbiological method (RMM) validation and implementation
- Quality, Regulatory and Product Development
- Failure investigations and root cause analysis
- Microbial data deviation investigations
- Audit response (e.g., FDA 483, warning letters, consent decree)
- Regulatory submission support associated with microbiological processes (e.g., NDA, ANDA, IND, BLA, marketing authorization)
- Pharmacopoeia (e.g., USP, Ph. Eur., JP) compliance
- Contact lens care and ophthalmic formulation development, manufacturing, stability testing and product release
- USP 797 compliance, pharmaceutical compounding of sterile preparations (compounding pharmacies)
Start FDA Expert SearchExpert Witness #264745
This expert is a professor at a College of Pharmacy, is a registered pharmacist, and has industry experience. This expert is widely published in the area of coatings and pharmaceutical product evaluation.
This expert holds Ph.D. and M.S. degrees in Pharmaceutics, an M.S. in Pharmaceutical Technology, and a B.S. in Pharmacy. An experienced expert witness and scientific consultant, this expert has supported the FTC and FDA as well as industry leaders, and is a named inventor on four patents/applications.
Start FDA Expert SearchExpert Witness #261725
This expert is a biomaterials and medical device product development expert with many years of experience. This expert leads a global team that develops pediatric Craniomaxillofacial implants from concept to global commercialization at a Fortune 500 medical firm. This expert has successfully developed, FDA cleared, and launched Bioresorbable, Bone Cement, and Distraction technologies.
This expert is the author of several published scientific articles and inventor of patents on Craniomaxillofacial products. This expert conducted a doctoral research in Biomaterials. This expert's degrees are Aerospace Engineering B.S., Mechanical Engineering M.S., and Biomedical Engineering Dr. Eng.
Start FDA Expert SearchExpert Witness #258317
This expert is the Director of a School of Pharmacy, where this expert is also a full Professor. This expert has been a member of the FDA Pharmacy Compounding Advisory Committee. This expert's research is focused on dissolution testing, formulation, mathematical modeling, computer aided manufacture and formulation and other related topics. This expert is the recipient of numerous honors and fellowships and he is well-published (books, chapters, peer-reviewed papers) and a frequent presenter and numerous academic and industry conferences. This expert holds five US Patents in pharmaceutics and is an experienced expert witness, having been deposed and testified at trial numerous times.
Start FDA Expert SearchExpert Witness #231534
This forensic biomedical engineering expert holds an M.S. in Mechanical Engineering and a Ph.D. in Biomedical Engineering, completed a post-doctoral fellowship at the Food and Drug Administration, and specializes in FDA approval, medical devices, and forensic biomedical engineering. This expert has served as a lead medical device reviewer at the FDA specializing in Class III and Class II medical devices, co-chaired a medical-device standards task group, taught at multiple universities, and developed original engineering courses.
Since leaving the FDA, this expert has worked in the medical device industry in Regulatory Affairs and has consulted for firms seeking FDA clearance or approval for devices. This expert operates an engineering consulting firm focused on forensic expert witness work and medical devices, works with a federal consumer product safety agency, and teaches engineering courses at universities and community colleges. This expert specializes in forensics, medical devices, engineering and reverse engineering, and R&D.
Start FDA Expert SearchExpert Witness #258302
This FDA industry expert holds a Ph.D. and is an executive regulatory and quality consultant for drugs, biologics, and vaccines, with over 10 years of experience as a principal investigator and group leader. This expert's skills encompass chemistry, manufacturing, and control (CMC), labeling, and compliance review of Investigational New Drug applications (INDs), new and abbreviated new drug applications (NDAs and ANDAs), and biological license applications (BLAs) for drugs, including small and complex molecules, therapeutic proteins, enzymes, monoclonal antibodies, and vaccines approved by the FDA or under clinical development.
This expert has experience with U.S. FDA principal investigator, quality (CMC), and labeling review of biologics, biotherapeutics, drugs, and combination products, as well as regulatory strategy and development of briefing packages for Pre-IND, IND, 510(k), PMA, ANDA, BLA, and other technical and regulatory documents for submission to the FDA.
This expert has experience with pre-approval inspections (PAIs), cGMP compliance, and audits of manufacturing sites for biologics, pharmaceuticals, and medical devices in compliance with 21 CFR Part 210 and 211, 21 CFR Part 820, 21 CFR Part 58, and 21 CFR Part 11. This work includes FDA 483 remediation, responses to FDA Warning Letters, consent decrees, and import bans.
This expert has conducted scientific and technical due diligence audits and analyses for investment firms, and has experience with quality system development, assessment, and implementation, as well as product quality assessment using concepts of ICH Q8 through ICH Q11 and FDA manuals.
This expert has extensive knowledge of biophysical, biochemical, molecular biology, and immunological techniques related to biologics and vaccines manufacturing, purification, and characterization. This expert also has in-depth knowledge of cGMP, ICH, EMA, and FDA regulatory guidelines, CMC regulatory guidelines, FDA law, relevant statutes of the FD&C Act and PHS Act, and global biologics manufacturing and development processes.
This expert's experience includes technology transfer, review and design of clinical trials, GCP and GLP audits, and development of strategies for FDA approval of multiproduct cGMP manufacturing facilities. This expert has also testified in arbitration involving cord blood stem cell manufacturing, including opinions on the applicability of cGTP versus cGMP regulations for human cells, tissues, and cellular and tissue-based products.
This expert has over two decades of experience in aseptic manufacturing, sterility assurance, and regulatory compliance for biologics and sterile drug products. As a former FDA Principal Investigator and CMC reviewer, this expert led inspections and compliance reviews focused on aseptic processing, environmental monitoring, cleanroom qualification, and contamination control. In post-FDA work, this expert has advised biopharmaceutical companies on cGMP remediation, process validation, and quality risk management for sterile manufacturing facilities, and has audited cGTP laboratories producing HCT/Ps.
Start FDA Expert SearchExpert Witness #279073
This FDA regulatory/compliance expert is an FDA regulatory expert witness and FDA compliance consultant skilled in the regulations and submissions of drugs, biologics, and medical devices. This expert is a former FDA reviewer with over 30 years of experience as an independent consultant to FDA-regulated companies of all sizes and over 10 years of experience as an FDA regulatory expert witness.
This expert has broad and deep skills in all phases of drug development, including the full lifecycle of initial regulatory strategy, clinical trial planning, execution, data analysis, submission preparation, and FDA review. This expert is an authority in FDA regulations and the work required for the collection, analysis, interpretation, and presentation of information to FDA. This expert also has expertise in understanding and responding to an FDA reviewer's actions and reactions and has developed and taught classes while assisting companies with the preparation of all parts of drug submissions.
This expert has worked as an FDA regulatory expert witness in over 50 cases, has been deposed over 20 times, and has testified multiple times.
Start FDA Expert SearchExpert Witness #279897
This FDA compliance expert is a former officer with the FDA and has over 30 years of domestic and international regulatory enforcement experience. Since leaving the FDA, this expert has practiced as an FDA regulatory compliance consultant helping firms meet FDA requirements. This expert has conducted hundreds of investigations and inspections involving medical devices, including Classes I, II, and III. This expert previously served as a medical device investigator and supervisor, covering all aspects of medical device regulations, including design controls, sterilization, and IDE inspections.
This expert is an experienced expert witness and litigation consultant. This expert has testified on behalf of the FDA in federal court and as a private consultant in state court depositions.
Start FDA Expert SearchExpert Witness #285925
This food safety expert is an expert witness and food safety consultant with over 30 years of experience, including senior leadership responsibility for assuring food safety in thousands of food facilities, including retail establishments, through a state Department of Health.
This expert also served as a Commissioned Officer with FDA enforcing FDA requirements in food establishments and was previously standardized by FDA to train and standardize state and local officials in enforcement of the FDA Model Food Code. This expert is also a past president of a national food and drug officials association and is an experienced expert witness, having worked on over 20 food safety cases, written expert reports, and testified at depositions.
Start FDA Expert SearchExpert Witness #289989
This FDA food labeling expert formerly held a leadership and supervisory role in FDA nutrition science review and directed an FDA nutrition programs division, managing activities related to the labeling of dietary supplements and conventional foods under FDA regulatory authority.
The work included FDA oversight of specific language determined to be required on labels. This expert has expertise in dietary supplement labeling regulations, prior expert witness experience, and substantial knowledge of FDA food and supplement labeling requirements.
Start FDA Expert SearchExpert Witness #303159
This FDA regulation expert holds a BS and PhD in chemistry, including doctoral work under a Nobel Prize-winning chemist, and operates a consulting practice that helps pharmaceutical companies comply with FDA regulations. Prior to consulting work, this expert held management roles in FDA-regulated industries, primarily in production at a major chemical company, and led cross-functional cost reduction, product development, and business optimization teams.
This expert has taught Regulatory Science at a well-regarded university, authored articles on compliance, chemistry, and general management, and participated in professional pharmaceutical engineering and chemistry associations.
This expert has served as an expert witness in FDA-related cases, prepared expert reports, and provided testimony.
Start FDA Expert Search