Texas
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...
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Review Fee
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This represents an expert’s hourly rate for participating in depositions. Experts may charge more for depositions that require them to travel, and some experts choose to bill a flat, daily or half-daily rate for deposition appearances.
Deposition Fee
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Court Fee
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This represents an expert’s hourly rate for participating in depositions. Experts may charge more for depositions that require them to travel, and some experts choose to bill a flat, daily or half-daily rate for deposition appearances.
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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