North Carolina
This expert has over 20 years of experience in pharmaceutical regulation and compliance. He earned his BA from Harvard College and his JD from Harvard Law School. His areas of expertise involve the regulation, compliance, governance, and enforcement of the pharmaceutical industry, including discovery, development, manufacturing, marketing, and sales. He previously served as a trial attorney for...
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Review Fee
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Deposition Fee
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Court Fee
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An FDA Regulations expert witness provides insight on compliance, regulatory standards, and industry practices. They can testify on violations, product safety, and approval processes.
Cases involving pharmaceuticals, medical devices, food safety, dietary supplements, cosmetics, or any product regulated by the FDA may require such an expert witness.
Yes. These experts can provide valuable insights into the complex process of drug approval and how deviations from this process can lead to legal issues.
Yes. Subspecialties can include pharmaceutical regulations, food safety standards, medical device regulations, cosmetic regulations, and more.
They can evaluate whether the manufacturer complied with FDA regulations regarding reporting adverse events and if failure to comply contributed to harm.
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