Having spent nearly a decade at the US Food and Drug Administration (FDA) in senior regulatory and policy roles, Bryant M. Godfrey advises FDA-regulated companies on a broad range of FDA regulatory, policy, compliance, enforcement, and strategic matters. Mr. Godfrey has a deep understanding of the issues that are of utmost importance to his clients. His experience encompasses a wide range of issues relating to product jurisdiction, medical product development and approval/clearance, labeling, advertising and promotion, scientific exchange, investigations of off-label marketing, post-marketing commitments and requirements, Current Good Manufacturing Practices (CGMPs), drug supply chain issues, medical device reporting, FDA warning letters and responses, dispute resolution, FDA inspections, recalls, administrative detention, import alerts and refusals, combination products, tobacco products, digital health, and he helps his clients to foster positive relationships with the agency.
While at FDA, Mr. Godfrey most recently was a Senior Regulatory Counsel in the Center for Tobacco Products, Office of Regulations, and also served as the Special Assistant/Senior Counsel to the Deputy Commissioner for Medical Products and Tobacco in the Office of the Commissioner. In these roles, he, among other things, established regulation policy for both medical products and tobacco products and wrote and contributed to the writing of various regulations, guidance documents, and other regulatory documents; managed Agency clearance of the same; and directed special projects, studies, or activities of concern to the Commissioner and/or Deputy Commissioner for Medical Products and Tobacco.
Prior to his role in the Center for Tobacco Products, Mr. Godfrey spent a number of years as a Senior Regulatory Counsel in FDA's Center for Drug Evaluation and Research.