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Christopher Pruitt is an associate in the firm's Washington, DC office in the Food & Drug and Government Contracts practice groups. He has experience advising manufacturers of drugs, devices, food, and other products on a range of regulatory issues involving the Food & Drug Administration, including compliance, transactional, and enforcement matters. Mr. Pruitt has particular experience with legal and regulatory issues related to FDA regulation of medical device software, promotion in social media, in vitro diagnostics, regulation of clinical laboratories, and food safety. Mr. Pruitt also advises drug and device manufacturers of legal and regulatory obligations associated with selling products to the Federal Government.
Representative Matters
- Evaluated software and mobile medical applications for compliance with FDA medical device regulations and policies.
- Represented a pharmaceutical manufacturer in an administrative hearing before FDA challenging a refusal to approve a supplemental application.
- Represented a pharmaceutical manufacturer in litigation challenging approval of a generic product.
- Co-authored a U.S. Supreme Court amicus brief on preemption of tort claims regarding the labeling of over-the-counter medicines.
- Provided strategic regulatory advice to pharmaceutical manufacturers evaluating companion diagnostic opportunities.
- Co-authored a successful Citizen Petition that advocated for FDA to exempt the storage of packaged foods from hazard analysis and preventive controls requirements.
Publications and Speeches
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