For nearly a decade before joining Foley Hoag, Bryant Godfrey held multiple senior regulatory and policy positions at the U.S. Food and Drug Administration (FDA). He served as Senior Lead Regulatory Counsel in the Center for Drug Evaluation and Research (CDER), Office of Medical Policy, Office of Prescription Drug Promotion (OPDP), where he led the regulatory counsel team and advised the office on complex legal, regulatory, and policy matters relating to the promotion of prescription drug products. Bryant Godfrey also served as Special Assistant and Senior Counsel to the Principal Deputy Commissioner in the Office of the Commissioner, and as Senior Regulatory Counsel in the Center for Tobacco Products (CTP).
Bryant Godfrey provides strategic regulatory advice on a wide range of FDA issues, including product jurisdiction, medical product development and approval/clearance, labeling, advertising and promotion, scientific exchange, investigations of off-label marketing, and post-marketing commitments and requirements. Bryant’s work at Foley Hoag also encompasses Current Good Manufacturing Practices (CGMPs), Clinical Laboratory Improvement Amendments (CLIA) compliance, drug supply chain, medical device reporting, FDA warning letters and responses, dispute resolution, FDA inspections, recalls, administrative detention, import alerts and refusals, combination products, cannabis-derived products, foods and dietary supplements, cosmetics, digital health (including artificial intelligence and machine-based learning technologies), and gene and cellular therapies.
While at FDA, Bryant Godfrey established regulation policy for both medical products and tobacco products, authored and contributed to the writing of various regulations, guidance documents, and other regulatory documents, managed Agency clearance processes, and directed special projects of concern to the Commissioner and Principal Deputy Commissioner. Bryant also participated on various Agency-wide First Amendment working groups to examine and assess current vulnerabilities and potential paths forward for the regulation of medical product promotion.
Bryant Godfrey also advises emerging life sciences and health technology companies on FDA regulatory strategy and healthcare compliance issues across every stage of growth — from pre-seed formation and initial product development through clinical trials, commercialization, and exit. He counsels founders, executives, and boards of early-stage pharmaceutical, biotech, medical device, and digital health companies on regulatory pathway selection, FDA submission strategy, promotional compliance, and the regulatory due diligence considerations that arise in venture financings, strategic partnerships, and M&A transactions. This work draws on Bryant Godfrey's deep understanding of the FDA regulatory landscape and his experience representing both established manufacturers and startups navigating complex approval and compliance frameworks.
Bryant Godfrey's practice at Foley Hoag also extends to international founders and companies. He regularly advises international pharmaceutical, medical device, biotech, and digital health companies seeking to bring their products and services to the U.S. market, guiding them through FDA regulatory pathway selection, pre-market submissions, U.S. labeling and promotional compliance requirements, and the broader healthcare regulatory landscape. Bryant Godfrey helps these companies develop and execute market-entry strategies that account for the unique demands of the U.S. regulatory environment, enabling them to land and launch in the United States efficiently and in compliance with applicable FDA and healthcare laws.
