Bryan Walsh uses his background in pharmaceutical policy and law to counsel clients on complex legal and scientific issues in the life sciences industry. Bryan helps clients navigate this legal framework throughout each stage of a product’s lifecycle, and advises clients on transactions involving life sciences companies.
His practice includes a broad range of regulatory matters, including assisting life sciences clients with product development, advertising and promotion, responding to FDA enforcement actions and related government investigations, and lifecycle management issues relating to drugs, biologics, and drug-device combination products. Bryan has advised clients drafting applications to support approval of therapeutics including investigational new drug applications, new drug applications, and biologics license applications, as well as De Novo requests and 510(k) applications for medical devices. Bryan also advises clients on intellectual property matters and litigation, and white collar investigation matters involving life science industries and products.
Bryan started his legal career as a research fellow in the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School and Brigham and Women’s Hospital, where he published on the impact of laws and regulations on innovation and use of therapeutics. Prior to joining McGuireWoods, Bryan served as a senior associate in the Pharmaceuticals and Biotechnology practice group of an AmLaw 25 firm.
Bryan serves as an adjunct professor at The George Washington University Law School. Bryan received his J.D. and Health Policy Certificate through the joint program at the George Washington University Law School and the Milken Institute School of Public Health. In law school, he served as vice president of the Moot Court Board and executive articles editor of the International Law Review.
- Counsel clients navigating FDA pre-submission meetings and appeals, including nonprofits and start-up companies bringing their first product to market.
- Prepare submissions for clients seeking orphan or pediatric rare disease designations, as well as those seeking priority review vouchers or other expedited approval designations.
- Draft responses for cell and gene therapy clients seeking relief from FDA clinical holds for novel therapies.
- Advise clients on complex regulatory exclusivity questions for drugs, biologics, and combination products.
- Analyze FDA-regulatory questions and prepare submissions for device and combination products.
- Conduct regulatory diligence for clients acquiring life sciences assets, with a focus on compliance programs, loss of exclusivity inquiries, and the interaction between FDA regulations and intellectual property/regulatory exclusivities.
- Conduct investigations and prepare client responses following receipt of FDA Warning and Untitled Letters related to Good Manufacturing Practice and Advertising and Promotion compliance issues.
Insights
- Author, FDA and EMA Provide Guiding Principles for AI in Drug Development, McGuireWoods Legal Alert, January 27, 2026