FDA REGULATIONS EXPERT WITNESSES

Expert Witness: E-511302
This highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and implementation, and over-the-counter and personal care product development. His former ...
Expert Witness: E-015772
This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. ...
Expert Witness: E-074885
This expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special Assistant for Legislative and Public Affairs in the Office of the ...
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-007167
This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug ...
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-065690
This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a ...
Expert Witness: E-057945
A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and as an analytical regulatory microbiologist. During his last ...

FDA REGULATIONS EXPERT WITNESS CASE STUDIES

FDA Expert Reviews Regulatory Hip Replacement Violations FDA REGULATIONS 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 device …

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

…  the device, the device manufacturer failed to comply with FDA requirements. An expert in medical device regulation was sought to discuss …  device manufacturers, enumerate the warnings and marketing regulations laid forth by the FDA, and explain post-market surveillance …

Cosmetic Product Causes Permanent Skin Damage FDA REGULATIONS 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 practices …

Competitors Dispute FDA Exclusivity For Generic Drug FDA REGULATIONS 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 …  applications for the same generic drug. An expert in FDA regulations with experience working in the office of generic drugs was sought …

Expert in Over-the-Counter Drug Labels Opines on Warning Standards FDA REGULATIONS 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 …