We’ll help you retain an industry-leading FDA Approval expert
Average FDA Approval Expert Witnesses Court Fees
Review Fee
Deposition Fee
Court Fee
This expert is a well respected and established Professor of Law specializing in ethics of the healthcare industry. He has testified before Congress and state legislatures and served on government commissions and advisory boards, including the Food and Drug Administration. He has provided training on conflicts of interest related to pharmaceutical good governance for various nations under the aegis of the World Health Organization. He has participated in meetings of the National Academy of Sciences, Institute of Medicine and worked for the World Health Organization. He has extensive experience in the fields of health law and policy, pharmaceutical policy, biomedical law, medical ethics, and more.
Professor, A Major Law School in Boston
Doctor of Philosophy (PhD), Brandeis University
Boston,
Massachusetts
This highly qualified and board certified psychiatrist has been practice for 33+ years. He earned his BS at the Massachusetts Institute of Technology and MD at Emory University. He completed residency training in psychiatry at Massachusetts General Hospital. This expert is a member of several professional organizations including the American Psychiatric Association and American Academy of Psychiatry and the Law. Currently, he is a clinical instructor at a university affiliated hospital. His clinical and forensic expertise includes assessment of complex diagnoses, treatment of depression, bipolar disorder, ADHD, and anxiety disorders. His expertise also includes dosing, side effects, drug interactions, and toxicity of psychotropic agents.
Clinical Instructor, An Ivy League university
Doctor of Medicine (MD), Emory University School of Medicine
Cambridge,
Massachusetts
This expert has over 35 years of experience in the field of psychopharmacology. He earned his BS from Massachusetts Institute of Technology and his MD from Emory University School of Medicine. He completed an internship in general surgery at Boston University Affiliated Hospitals and a residency in psychiatry at Massachusetts General Hospital. He is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Academy of Psychiatry and Law. He previously served as a staff psychiatrist for Harvard Vanguard Medical Associates, as a clinical supervisor for Lane Health Center at Northeastern University and as a psychopharmacology consultant for the University of Massachusetts. This expert is currently a psychiatrist at a private practice, a staff psychiatrist at a hospital in Massachusetts and a clinical instructor of psychiatry at an Ivy League university.
Clinical Instructor, An Ivy League university
Doctor of Medicine (MD), Emory University School of Medicine
Cambridge,
Massachusetts
This highly-qualified expert has 14 years of experience in the field of biopharmaceutical development, having earned her BS in biology from the University of North Carolina and her PhD in genetics from the University of California at San Francisco. Her work focuses on drug development with a particular focus on gene and cell therapies, including those with the following elements: AAV, Adenovirus, CRISPR, Zfn, Endonuclease, CAR-T, mRNA, LNP, Lentivirus, HSPC. She has worked in positions such as principal consultant for Halloran Consulting Group, the founder and CEO of Tremont Therapeutics, the senior director of Shire PLC, and the executive director of CRISPR Therapeutics. She is also involved in research in her field as an author of several scientific articles. This expert currently works as the principal at a drug development consulting company in Massachusetts.
Principal, A drug development consulting company in MA
Doctor of Philosophy (PhD), University of California, San Francisco
Charlestown,
Massachusetts
Related Specialties
Find Fda Approval Expert Witnesses In:
Alabama
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maryland
Massachusetts
Michigan
Mississippi
Missouri
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
What Can a FDA Approval Expert Witness Opine On?
Preclinical Testing
Assess safety and efficacy in labs.
Investigational New Drug Application
Submit data for human trial approval.
Phase 1 Clinical Trials
Test drug on a small group of subjects.
Phase 2 Clinical Trials
Evaluate effectiveness in larger patient groups.
Phase 3 Clinical Trials
Confirm effectiveness through extensive testing.
New Drug Application Submission
Request approval for market release.
FAQs for Fda Approval Expert Witnesses
What is a fda approval expert witness?
An FDA approval expert witness is a specialist who explains FDA rules and drug or device approval processes in legal cases. They assist by reviewing records, offering opinions, and testifying to clarify FDA compliance issues.
What types of cases may benefit from the insights of an FDA Approval expert witness?
An FDA approval expert witness supports drug, device, biologic, clinical trial, labeling, marketing, compliance, and product liability cases involving FDA regulatory standards.
How can an FDA Approval expert witness evaluate regulatory compliance timelines?
An FDA approval expert witness evaluates regulatory compliance timelines by comparing documented development, submission, and review milestones against FDA guidance and statutory deadlines.
What qualifications should an FDA Approval expert witness possess for complex litigation?
An FDA approval expert witness should have advanced scientific or medical training, regulatory experience, and a proven track record with FDA approval processes and complex litigation.
How does an FDA Approval expert witness assess adequacy of premarket submissions?
An FDA approval expert witness assesses adequacy of premarket submissions by comparing study design, data quality, and labeling to current FDA regulations, guidance, and review standards.
What is Expert Institute’s process for selecting fda approval expert witnesses?
Expert Institute delivers a tailored approach to connect you with top-tier experts. We identify actively practicing professionals who meet your exact criteria for specialty, experience, litigation background, fee structure, credentials, location, and more.