FDA Expert Witnesses

fda expert testimony

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FDA expert witness candidates typically have a PhD, and years of experience in healthcaredrug development, food and drug safety, pharmacologyFDA regulation, and/or regulatory affairs. 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. 

The US Food and Drug Administration (http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation) is responsible for protecting public health by quality control and supervision of a wide range of products. The FDA oversees drugs, food, medical devices, radiation-emitting products, vaccines, biologics, animal and veterinary products, cosmetics, and 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. 

Litigation support by an FDA expert witness could include an expert report, expert opinion, depositions, and trial testimony. In addition, clients may seek an FDA expert for pre-litigation consulting work. 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 project include:

Cahn Litigation Services has the experience required to turn a search for an expert witness around quickly.

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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.

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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.

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Expert 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.

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Expert 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.

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Expert 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.

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Expert 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.

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Expert 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)

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Expert 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.

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Expert 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.

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Expert 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.

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