FDA APPROVAL EXPERT WITNESSES

Expert Witness: E-006733
This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic legal analysis of companies' Quality Management Systems (ISO 9001), ...
Expert Witness: E-056391
This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and regulatory due diligence. Her experience includes serving as a member of the ...
Expert Witness: E-053014
This certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory Affairs at medical device firms that manufacture class II and class III products. ...
Expert Witness: E-028291
This extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise in the translation of complicated medical terminology into language the ...
Expert Witness: E-037585
This expert has been practicing anesthesiology at a 600 bed hospital in Southern California for nearly a quarter century. A graduate of UC Riverside, he attended medical school at Loyola Stritch School of Medicine in Illinois and thereafter completed residencies in General Surgery and Anesthesiology at Loma Linda University Medical Center. A diplomate of the American Board of Anesthesiology and an active member of the American Society of Regional Anesthesia and Pain ...
Expert Witness: E-035914
This expert has decades of experience in pre-clinical through Phase IV research. Apart from standard statistical methods, he has special expertise in adaptive methods, recurrent event methods, experimental design, assays, mathematical modeling and simulation, data-mining and super-computer applications. As an independent statistician he serves on numerous data and safety monitoring boards and regularly interacts with FDA and EMA personnel on behalf of his clients. With ...

FDA APPROVAL EXPERT WITNESS CASE STUDIES

FDA Expert Reviews Regulatory Hip Replacement Violations FDA APPROVAL Expert Case

FDA Expert Reviews Regulatory Hip Replacement Violations

…  did not provide proper adverse event reports to the FDA as the data was coming in. An expert in FDA regulations was sought to discuss how the labeling and warnings on the …

Pharmaceutical Company Allegedly Involved In Opioid Kickback Scheme FDA APPROVAL Expert Case

This case involves the alleged improper marketing of a particular opioid pain medication by a defendant pharmaceutical company. The allegations claimed that the defendant fraudulently marketed the drug in question for off-label uses and that the defendant …

Medical Device Manufacturer Allegedly Violates FDA Regulations FDA APPROVAL Expert Case

…  and hair loss. It was alleged that after being granted approval for the device, the device manufacturer failed to comply with FDA requirements. An expert in medical device regulation was sought to discuss …

Cosmetic Product Causes Permanent Skin Damage FDA APPROVAL Expert Case

Cosmetic Product Causes Permanent Skin Damage

…  It was alleged that the product was not in compliance with FDA and that the cosmetic manufacturer had known about the dangers of using the product and failed to warn the public. An expert in FDA regulations and particular familiarity with cosmetics regulatory good …

Competitors Dispute FDA Exclusivity For Generic Drug FDA APPROVAL Expert Case

Competitors Dispute FDA Exclusivity For Generic Drug

…  case involves a Food and Drug Administration (FDA) exclusivity dispute surrounding the development of a generic drug. On the …  in the office of generic drugs was sought to discuss the approval process for generics and determine the proper eligibility for generic …

Expert in Over-the-Counter Drug Labels Opines on Warning Standards FDA APPROVAL Expert Case

This case involves an individual who’s chronic multiple sclerosis allegedly worsened after she took an over the counter diarrhetic. She was prescribed the diarrhetic by her doctor, and after taking the drug, she suffered from involuntary muscle movements …