FDA Regulations Expert Witness

FDA Regulations Expert Witnesses

E-511302

Medical Device Regulations Expert

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 ...

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E-015772

FDA Expert

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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, ...

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E-074885

FDA Regulations, Congressional oversight Expert

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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 ...

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E-006733

Forensic Legal Analysis Expert

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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 ...

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E-007167

Pharmaceutical and FDA Regulations Expert

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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 ...

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E-056391

FDA Regulatory Affairs Expert

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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 ...

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E-065690

FDA Regulation and Compliance Expert

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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 ...

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FDA Regulations Expert Witness Case Studies

FDA Regulator’s Testimony Deemed Irrelevant as Medical Device Expertise

Feb 27 2020 FDA Regulations

Court: United States District Court for the Eastern District of Pennsylvania Jurisdiction: Federal Case Name: Ctr. City Periodontists, P.C. v. Dentsply Int’l, Inc. Citation: 2017 U.S. Dist. LEXIS 115373 Facts The plaintiffs, a group of dental professionals, brought a class…

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Class Action, Compliance, Dentistry

Insufficient Pre-Market Screening Allegedly Causes Pelvic Medical Device Failure

Jan 9 2020 FDA Regulations

Court: United States District Court for the Southern District of West Virginia, Charleston Division Jurisdiction: Federal Case Name: Winebarger v. Boston Sci. Corp. Citation: 2015 U.S. Dist. LEXIS 53892 Facts This Multi-District Litigation involved the use of transvaginal surgical mesh…

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FDA Approval, FDA Regulations, Medical

FDA Expert Opinion Irrelevant To Breach of Warranty Discussion In Medical Device Class Action

Jul 30 2019 FDA Regulations

Court: United States District Court for the Eastern District of Pennsylvania Jurisdiction: Federal Case Name: Ctr. City Periodontists, P.C. v. Dentsply Int’l, Inc. Citation: 321 F.R.D. 193 Facts The plaintiffs brought this action against the defendants for breach of express…

FDA Expert Reviews Regulatory Hip Replacement Violations

Mar 26 2019 FDA Regulations

This case involves a hip replacement device MDL. It was alleged that the device manufacturer 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…

Manufacturer Is Accused Of Mislabeling Over-The-Counter Products

Dec 11 2018 FDA Regulations

This case involves a distribution rights dispute between a skincare products company and another member of their LLC. The defendant company had exclusive worldwide distribution rights for certain products supplied by the plaintiff entity. However, under their contract, the plaintiff…

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Compliance, Distribution, FDA Approval

Pharmaceutical Company Allegedly Involved In Opioid Kickback Scheme

Oct 30 2018 FDA Regulations

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 was negligent in their…

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Drug, FDA Approval, FDA Regulations

Medical Device Manufacturer Allegedly Violates FDA Regulations

Oct 16 2018 FDA Regulations

This case involves numerous plaintiffs who suffered complications related to a birth control medical device. The plaintiffs suffered perforation of the uterus and other organs, migration of the device throughout the body, as well as immune reactions to the device…

Competitors Dispute FDA Exclusivity For Generic Drug

Apr 10 2018 FDA Regulations

This case involves a Food and Drug Administration (FDA) exclusivity dispute surrounding the development of a generic drug. On the same day, 2 pharmaceutical companies submitted abbreviated new drug applications for the same generic drug. An expert in FDA regulations with experience…

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FDA Approval, FDA Regulations, Pharmacy

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

Feb 1 2018 FDA Regulations

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 and could not feel…

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Drug, FDA Approval, FDA Regulations

Top Level Disciplines

FDA Regulations Disciplines

Engage experts with unparalleled credentials, demeanor, and experience to deliver case winning performances at deposition and trial.

Expert Witness Specialty Index

FDA Regulations Expert Witness

FDA Regulations Expert Witnesses

Medical Device Regulations Expert

FDA Expert

FDA Regulations, Congressional oversight Expert

Forensic Legal Analysis Expert

Pharmaceutical and FDA Regulations Expert

FDA Regulatory Affairs Expert

FDA Regulation and Compliance Expert

FDA Regulations Expert Witness Case Studies

FDA Regulator’s Testimony Deemed Irrelevant as Medical Device Expertise

Insufficient Pre-Market Screening Allegedly Causes Pelvic Medical Device Failure

FDA Expert Opinion Irrelevant To Breach of Warranty Discussion In Medical Device Class Action

FDA Expert Reviews Regulatory Hip Replacement Violations

Manufacturer Is Accused Of Mislabeling Over-The-Counter Products

Pharmaceutical Company Allegedly Involved In Opioid Kickback Scheme

Medical Device Manufacturer Allegedly Violates FDA Regulations

Competitors Dispute FDA Exclusivity For Generic Drug

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

Top Level Disciplines

FDA Regulations Disciplines

Connect with the FDA Regulations expert witness you need to win your case.

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