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Expert Bio

Primary Area of Expertise
FDA Regulatory Affairs
Profile
Former FDA reviewer with experience being deposed and testifying about safety and FDA compliance in medical device and drug cases including hip implants, electronic implants, sulindac, fentanyl, Actos, cancer drugs, and ADHD drugs. Provide expert opinions on the drug approval process, trade secrets and the safety role of Institutional Review Boards. Over 20 years of experience applying a broad and deep set of skills in drug, biologic and medical device development in solving FDA regulatory problems in companies of all sizes.

Skilled at writing expert reports that describe (or explain) safety and compliance-related errors committed by FDA-regulated companies and their outsourcing partners. Expert in FDA regulatory requirements for software development and data integrity.

Specialist in analyzing drug/device safety-related data and FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it?

Skilled in writing 510(k), IDE, PMA, IND, NDA, SOP