Maryland
This highly-qualified expert has nearly 30 years of experience as an epidemiologist and nurse-midwife, with demonstrated experience in medical device safety including gynecologic surgical mesh, breast implants, hip replacement, cardiovascular and dermatologic devices, post-market surveillance, and pharmacoepidemiology. She received her BS in biology from the University of Illinois and a diploma...
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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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