James A. Boiani

Overview

“The most valuable thing I can do for a client is help them see around the next regulatory corner before they get there.” —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.

Focus Areas

Representative Experience

View Experience Highlights

Regulatory Strategy and Product Development

Advised pharmaceutical developers on complex IND issues, including clinical and nonclinical trial design, endpoint selection, human factors studies, and deviations from standard FDA recommendations based on fact-specific scenarios.
Supported NDA applicants with literature-based 505(b)(2) applications, advocated for a favorable extent of reliance on prior FDA decisions to reduce testing requirements, successfully obtained dosage form change suitability petitions, and helped clients navigate fixed-dose combination drug policies.
Advised on the use of real-world data and evidence (RWD/RWE) in regulatory submissions, and their use in product labeling and advertising.
Counseled clients on regulatory issues and strategies for novel technologies, such as neurostimulation for substance use disorder, various home-based diagnostics, mitochondrial replacement therapy (MRT), a new molecular entity (NME) product for medical imaging, treatment-planning SaMD, and supported implementation of strategies where applicable (e.g., Q-Subs, 510(k)s, and De Novo submissions; Pre-INDs, Pre-NDA meetings, and NDAs).
Addressed jurisdictional issues for novel products through request for designation (RFD) and Pre-RFD submissions and advised on combination product issues pertaining to complex drug delivery systems and wound care products.
Assisted clients in developing product bridging strategies to reduce data burdens for drugs, devices, and combination products, and advised on suitability petitions for dose formulation changes.
Advised clients on life cycle management issues and opportunities with respect to product formulation and indication development, as well as market exclusivities (e.g., pediatric, orphan, Hatch-Waxman, biosimilars), patent term extensions, and Orange and Purple Book patent listings.
Pursued orphan drug designations and breakthrough designations for drugs and medical devices on behalf of clients at multiple stages of development.
Represented small companies in pursuing PDUFA and MDUFA FDA user fee waivers and fee reductions for small businesses and innovative products.
Advised on launch of human cell, tissue, and cellular and tissue-based products (HCT/Ps), good tissue practice compliance, and promotional matters.
Advised on the USDA regulation of animal diagnostics, including bounds of regulation and pathway to approval.

Digital Health, AI, and Diagnostics

Helped a client successfully pursue TEMPO market authorization for a novel digital medicine solution.
Advised clients on complex digital health regulatory issues, including the use of AI in regulated and non-regulated products, the bounds of non-regulated clinical decision support software, and the regulatory treatment of non-regulated wellness products.
Supported clients in the telemedicine space with respect to FDA and FDA-adjacent matters (e.g., 503A and 503B drug compounding; clinical decision support carve-outs in the 21st Century Cures Act).
Advised on joint FDA in vitro diagnostic (IVD) and CLIA lab developed test (LDT) commercialization strategies.

FDA Compliance and Enforcement

Assisted pharmaceutical, biotechnology, medical device, dietary supplement companies, and pharmacies in managing FDA inspections and developing remediation strategies in response to Form 483 observations and warning letters, including matters involving cGMP, quality system, promotional labeling and advertising, and post-market surveillance deficiencies.
Conducted trainings on advertising and promotion and other compliance-related matters.
Counseled biotech, pharma, medical device, and dietary supplement clients on adverse events and MDR reporting obligations, recalls, and other safety-related actions.
Advised on CPSC consumer product safety issues, recalls, and related matters
Helped clients address the import and export of FDA-regulated products for research, marketing, and further manufacturing, and provided country-of-origin analyses for Buy America Act (BAA) and Trade Agreements Act (TAA) compliance.
Represented clients in compliance matters involving FDA-regulated foods, dietary supplements, and cosmetics.
Supported clients in CAPA investigations and broader remediation activities with respect to GMP and promotional issues.
Conducted internal investigations related to GMP and clinical research issues, and helped address concerns with respect to alleged data integrity issues.
Helped address compliance issues related to the Mammography Quality Standards Act (MQSA).
Provided expert witness statements with respect to COVID-19 diagnostic test policies in the context of arbitration proceedings.
Addressed commercial disputes related to complex regulatory matters pertaining to interpretation of FDA requirements and reimbursement coding, product liability, trade libel, contractual breach related to supply agreements, and other matters.
Assisted clients with federal and state licensure issues related to pharmaceutical and device manufacturing and distribution, tissue banks, blood banks, and the collection of research specimens.
Advised on psychedelics regulation at the federal and state level with respect to medical applications, manufacturing, and research, and addressed other controlled substance issues in the research and development context.

Life Sciences Transactions and Investor Services

Provided buy-side and sell-side FDA regulatory due diligence in mergers and acquisitions, funding raises, and lending transactions spanning pharmaceutical and biotechnology companies, medical device manufacturers, CROs, CMDOs, API manufacturers, and data aggregators and analyzers.
Advised on FDA and health regulatory risk disclosures in IPO registration statements and periodic SEC filings for life sciences companies at multiple stages of development.
Developed regulatory narratives for Series A through late-stage fundraising materials, helping companies present their regulatory status and pathway clearly to investors unfamiliar with FDA processes.
Advised on change of ownership (CHOW) requirements pertaining to federal and state approvals, registrations, permits, and licensure.