James Boiani

James A. Boiani, MS, Esq. is a Shareholder at Epstein Becker Green, a law firm dedicated to helping clients, large and small, in the life sciences and healthcare. James has deep experience in FDA regulation of pharmaceuticals & biologics, medical devices, HCT/Ps, and diagnostics, helping innovators develop premarket strategies, prepare FDA submissions (e.g., Q-Subs, Pre-INDs, NDAs, De Novos), advocate for sensible regulation that advances innovation and patient care, navigate postmarket compliance and responses to FDA-483s and warning letter, and support development of commercialization strategies that marry product authorization and reimbursement strategies. He also understands the contours of non-FDA regulated offerings (e.g., clinical decision support software, lab developed tests), and helps clients develop commercial strategies for such products and services. In addition, James assists clients in commerical disputes which involve regulatory and reimbursement matters, advertising and promotional compliance per FDA and FTC standards, Lanham Act matters, and other trade-related issues, and leads internal investigations on client's behalf in assessing allegations of regulatory noncompliance.

In addition, James works with trade associations on complex regulatory matters (e.g., regulation of antimicrobial wound dressings, combination products, and point-of-care diagnostics), supports Congressional lobbying efforts to improve innovation, and advises investors in the life sciences – performing due diligence of potential investment targets and advising on the impact of shifting regulatory landscapes that could affect valuation and business planning. Prior to becoming an attorney, James studied chemistry and MIT and Cornell University, and lives just outside of Washington, D.C. with his wife, five children, and nine chickens.