- For a hip implant, write an expert report describing the manufacturer’s lack of FDA
compliance in their efforts to obtain a 510(k) approval.
- Write a report explaining why the Warning Section of the label for a generic version of sulindac was deficient.
- Assist attorneys in identifying documents to request during discovery and advise on
questions to ask during depositions.
- Identify FDA regulatory deficiencies in the adverse event reporting of a breast cancer drug
and describe the resulting deficiencies in the drug’s label.
- For a hip implant, write an expert report describing the company’s non-compliance with FDA labeling requirements and reporting of adverse event information.
- Write a report describing why the processes establishing the stability of a drug product
met FDA compliance requirements for marketing.
- Review the statistical design of a clinical trial intended to compare the effectiveness of two
drugs. Determine if the study design was manipulated to mask the weakness of one drug
over the other.
- Review and find weaknesses in an expert’s report on the adverse event reporting of
fentanyl. Write a report of findings.
- Analyze the content of a drug IND submission to identify trade secret content.
- Explain the complexities of the FDA drug approval process to a jury.
- Former FDA reviewer
- Write expert reports on safety and FDA compliance of hip implants
- Skilled in depositions and testimony
- Vast experience as an auditor of FDA compliance
- Expert in software development
- Confirm data integrity
- Speaker at FDA meetings with drug and medical device companies
- Critique adverse event reporting
- Support attorneys in cases involving sulindac, fentanyl, Actos, breast cancer drugs and ADHD drugs
- Perform statistical analysis
- Identify, prevent and solve FDA compliance problems for drug and device companies of all sizes
- Trained over 50,000 people on more than 40 FDA-related technical and compliance topics
- Write submissions, SOPs, study reports
- Testify as an FDA expert witness in drug, biologic, and medical device cases