Theodore M. Thompson, CIPP

Experience

• Advised as an expert witness on FDA medical device reporting regulation and guidance in federal qui tam (False Claims Act) litigation.
• Drafted quality agreements and counseled multi-national corporation with substantial manufacturing expertise but without in-house FDA experience.
• Drafted internal procedures and negotiated manufacturing agreements for cosmetic manufacturer to comply with the Modernization of Cosmetic Regulation Act (MoCRA).
• Counseled cosmetic manufacturer on product labeling requirements under FDA regulations.
• Reviewed competitor’s website and submitted findings to FDA’s Office of Regulatory Affairs (ORA) citing non-compliance with FDA advertising laws and regulations.
• Drafted clinical research agreements for medical device manufacturer conducting a multi-site study in the U.S. and Europe.
• Drafted Business Associate Agreements (BAA) for laboratory service provider and various health care facilities. 
• Reviewed device manufacturer’s advertising and promotional material to ensure compliance with FDA and FCC laws and regulations.
• Counseled clients on the application of the CAN-SPAM Act and Telephone Consumer Protection Act (TCPA) to their advertising practices.
• Drafted and updated privacy policies for manufacturer’s websites to ensure compliance with changing data privacy laws.
• Drafted quality agreement for clinical-stage biologics manufacturer with complex manufacturing processes across multiple international jurisdictions.
• Created a pharmaceutical company’s Quality System to comply with FDA regulatory requirements, allowing the client to legally market their product.
• Audited medical device company’s quality system to position client as a target for acquisition.
• Counseled client on best practices for complaint handling and medical device reporting under 21 C.F.R. Parts 820 and 803, respectively.
• Counseled client on safely marketing their product under Section 361 of the Public Health Services Act and in accordance with FDA guidance.

Professional & Civic Activities