James A. Boiani

Life sciences companies navigating FDA regulatory strategy from early development through post-market compliance turn to attorney James Boiani for counsel that bridges deep scientific knowledge and practical legal guidance.

James advises large and small innovators in pharmaceuticals and biotech, medical devices, in vitro diagnostics, digital health, wellness, medical foods and supplements, and clinical laboratory testing, as well as life sciences trade associations, on the full spectrum of FDA regulatory matters. His chemistry degrees from Cornell University and the Massachusetts Institute of Technology (MIT), and his earlier work as an environmental chemist shape how he reads the science behind agency submissions and compliance challenges.

James’s FDA practice covers the entire product life cycle. He provides representation and counsel on investigational and pre-approval matters (such as Pre-IND/IDEs and Q-Subs, INDs/IDEs, and documenting IND/IDE exemptions) and on marketing submissions (including NDAs, BLAs, ANDAs, 513(g)s, 510(k)s, De Novo requests, and PMAs). James helps clients respond to FDA clinical holds, complete response letters, additional information requests, and deficiency letters. When FDA issues an adverse decision that cannot be overcome at the review level, he prepares and pursues administrative appeals on behalf of clients. His work also addresses complex development issues arising from novel product characteristics, nonstandard trial designs, and the evolving use of real-world evidence and emerging technologies in the approval process.

For compliance matters, James guides clients through FDA inspections, enforcement correspondence, and remediation. He advises on the full range of post-market obligations, from adverse event and MDR reporting and recalls to advertising and promotional compliance. His practice spans the breadth of FDA-regulated product categories, including areas where FDA jurisdiction intersects with those of the FTC, the CPSC, the DEA, and the USDA. He also assists clients in disputes involving advertising and promotion covering FDA and FTC compliance matters, as well as regulatory matters affecting commercial agreements, such as supply and distribution arrangements.

In addition, James supports clients in investment and fundraising transactions involving life sciences companies and innovative technologies, providing regulatory due diligence, SEC disclosure assistance, and FDA narrative development across the full range of deal types and company stages. The transactions he has worked on range from a few million dollars to more than $12 billion and span the life sciences continuum, from early-stage biotechnology companies and contract research organizations (CROs) to API manufacturers and data analytics firms.

Every year since the fall of 2018, James has been a guest lecturer at Cornell University, co-teaching a digital health law course where he covers FDA regulation.

What James Delivers for Clients

• Scientific Fluency as a Client Advantage: James’s chemistry degrees from MIT and Cornell are not simply biographical details—they inform how he evaluates the scientific basis for regulatory positions, analyzes clinical and nonclinical data, and identifies opportunities or vulnerabilities in a submission that a lawyer without a scientific background might miss.
• Full Life Cycle Regulatory Coverage: A product's regulatory history is cumulative, and the strategic decisions made in early development affect every phase that follows. Because James has advised clients from pre-IND/Q-Sub meetings through post-approval life cycle management, he brings that continuity to every engagement, recognizing issues and opportunities that only become visible across the full arc of a product's development.
• Diligence That Closes Transactions: In life sciences transactions, regulatory risk is often the variable that determines whether a deal closes, at what valuation, and on whose terms. James gives investors, acquirers, and lenders a clear-eyed assessment of FDA regulatory exposure before they commit, drawing on experience across deal structures ranging from early-stage funding rounds to multibillion-dollar acquisitions.
• Digital Health and AI Counsel: James advises clients on some of the most rapidly changing areas of FDA jurisdiction: AI-enabled medical devices, the boundaries of non-regulated clinical decision support software, and non-regulated wellness products, where governing frameworks continue to evolve, and the cost of misjudging the line between regulated and non-regulated products is significant.
• Enforcement Preparedness and Response: FDA inspections and enforcement actions are far more manageable when a company has already built the quality systems, documentation practices, and compliance culture that regulators expect to find. James works with clients on the front end to reduce enforcement exposure, and if FDA does act, he helps them promptly resolve the issue rather than prolong it.

Education

• George Mason University School of Law (J.D.)
• Cornell University (M.S.)
• Massachusetts Institute of Technology (B.S.)

Professional & Community Involvement

• American Bar Association
• Coalition for CLIA Waiver Reform, Founder and General Counsel
• Combination Product Coalition, Deputy General Counsel

Past Events