Overview
Attorney James Boiani has extensive experience in FDA and CLIA legal and regulatory matters, having worked with large and small medical device companies (including many in vitro diagnostic companies), pharmaceutical companies, clinical laboratories, and trade associations in the life sciences industry on a variety of FDA- and CLIA-related issues.
His practice focuses on the following:
- Advising on FDA compliance matters, with an emphasis on current good manufacturing practices ("cGMPs") and quality systems; post-market surveillance and safety reporting; recalls; and advertising and promotion
- Representing clients in the FDA product approval and clearance process (e.g., NDAs, BLAs, PMAs, 510(k)s, and CLIA waivers)
- Identifying and capturing regulatory opportunities in product development and lifecycle management
- Ensuring clinical laboratory regulatory compliance (e.g., CLIA compliance)
His experience includes:
- Assisting companies in pre-enforcement situations by helping them manage FDA inspections; working on responses to FDA-483 observations, untitled letters, and warning letters; developing and implementing remediation strategies to correct compliance issues; evaluating and helping address CLIA audit findings; and advising clients on handling difficult FDA- or CLIA-related compliance issues more generally
- Advising clients on adverse event (AE) and medical device report (MDR) reporting, recalls, and associated issues; of recent note, James has served as the primary outside legal advisor to a major medical device company for more than over two years, providing extensive support on all facets MDR reportability, recall decisions, recall communications to customers, recall reports to regulatory agencies and associated agency communications, and recall-related issues (such as root cause investigations and CAPAs), from both a case-specific and global corporate policy standpoint
- Founding and serving as General Counsel of the Coalition for CLIA Waiver Reform, which is working to advance point-of-care diagnostic testing
- Representing individual medical device manufacturers in matters involving CLIA waivers
- Helping companies address advertising and promotional issues, including the review of promotional pieces, policy development regarding off-label uses and associated issues (e.g., handling unsolicited requests for off-label information and good reprint practices), the development of communication strategies, and conducting intensive advertising and promotional trainings for marketing and sales, scientists, and management
- Working with compounding pharmacies and trade associations to address new FDA regulatory oversight and compliance matters
- Representing and counseling clients in FDA drug, medical device, and biological approval- and clearance-associated matters, such as application submissions (i.e., NDAs, BLAs, ANDAs, PMAs, and 510(k)s), responses to FDA complete response/deficiency letters, administrative appeals of adverse FDA decisions, clinical and nonclinical trial design issues, and complex 505(b)(2) and combination drug policy issues
- Counseling clients on issues regarding combination products (e.g., preparing requests for designation and advising on cGMPs, registration, and listing) and the development of companion diagnostics, and supporting policy initiatives of trade associations in the area of companion diagnostics
- Advising drug developers on lifecycle management issues and opportunities
- Assisting pharmaceutical and biotechnology firms in obtaining pediatric market exclusivities, Hatch-Waxman exclusivities, and patent term extensions
- Representing clients in matters involving drug and medical device development (i.e., IND and IDE issues) and other pre-approval and pre-clearance issues (e.g., Emergency Use Authorizations)
- Representing small and start-up biotechnology firms pursuing FDA user fee waivers, and advising clients on user fee issues
James has also worked for the Veterans Pro Bono Consortium, which provides free legal services to veterans.
Prior to becoming a lawyer, James earned degrees in chemistry from the Massachusetts Institute of Technology and Cornell University, and worked as an environmental regulatory consultant. In the fall of 2018, James returned to Cornell as a guest lecturer, co-teaching digital health law at Cornell Tech.
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Focus Areas
Services
- Artificial Intelligence
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Digital Health
- Drug and Medical Device Distribution
- Drug Pricing Policy & Reporting
- FDA Inspections and Enforcement
- Health Care
- Health Care and Life Sciences Investor Services
- Health Policy and Legislation
- Industry Research and Clinical Trials
- Life Sciences
- Life Sciences Due Diligence
- Opioids
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
Experience
Recognition
- The Best Lawyers in America, FDA Law (2025)
- Washington DC Rising Stars, Food and Drugs (2014)
Credentials
Education
- George Mason University School of Law (J.D., 2004)
- Cornell University (M.S., 1998)
- Massachusetts Institute of Technology (B.S., 1996)
Bar Admissions
- District of Columbia
- Virginia
Court Admissions
- U.S. Court of Appeals for the District of Columbia Circuit
- U.S. District Court, District of Columbia
Professional & Community Involvement
- American Bar Association
Media
Events
Past Events
- Israel Rise US Program: US Reimbursement and Payor Systems
- June 9, 2022
Insights
Insights
- Media CoverageJames Boiani Quoted in “Supplement Makers Try to Latch On to GLP-1 Boom”2 minute read
- Firm Announcements
Epstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 2025
14 minute read - Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 minute read
- BlogsIt’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices ...8 minute read
- Media CoverageJames Boiani Quoted in “$42M Rat-Infestation Fine Underscores Sanitation Risks Facing Warehouses”3 minute read
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved” ...2 minute read
- Media CoverageJames Boiani Quoted in “FDA Braces for High Court, Final Rule Moves in Election Year”3 minute read
- Media CoverageJames Boiani Quoted in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom” ...2 minute read
- BlogsFDA LDT Webinar Serves as a Reminder to Industry to Submit Comments on the Proposed Rule3 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
- Media CoverageJames Boiani Quoted in “NY State Database Offers Glimpse into Laboratory-Developed Testing Landscape”3 minute read
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 minute read
- BlogsUnpacking Averages: Analyzing the Relationship Between MDRs and Recalls21 minute read
- BlogsFDA’s LDT Proposed Rule Heads to the White House2 minute read
- BlogsTAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year27 minute read
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New ...26 minute read
- Media CoverageJames Boiani Quoted in “The Hazy Future of the VALID Act”2 minute read
- Media CoverageJames Boiani Quoted in “FDA Resumes Move to Regulate LDTs, Likely Setting Up Legal Battle with Lab Industry” ...3 minute read
- BlogsFDA Issues Orphan Drug Exclusivity Policy That Could Be a Catalyst for Future Litigation8 minute read
- PublicationsCongress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs ...14 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- Media CoverageJames Boiani Quoted in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say” ...3 minute read
- BlogsThe VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition6 minute read
- Publications
Deconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision
16 minute read - Media CoverageJames Boiani Quoted in “FDA Has Broad Regulatory Options for Mixing Covid Boosters”3 minute read
- Media CoverageJames Boiani Quoted in “Covid Test Makers Told to Update Labeling in Wake of Mutations”2 minute read
- Media CoverageJames Boiani Quoted in “FDA Class I Medical Device Recalls on Track to Break Record in 2021”3 minute read
- Media CoverageJames Boiani Quoted in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration” ...3 minute read
- Media CoverageJames Boiani Quoted in “Virus Testing Push Leaves FDA Lab Oversight in ‘a Bizarre Limbo’”3 minute read
- Media CoverageJames Boiani Quoted in “Botched Covid Plasma Announcement Clouds FDA’s Vaccine Process”1 minute read
- BlogsFDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review ...8 minute read
- BlogsCurrent Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk ...5 minute read
- Media CoverageJames Boiani Quoted in "Psychedelic Meds Are Opening a New Frontier for Legal Work"2 minute read
- Media CoverageJames Boiani Quoted in "Startups Spar with FDA Over What Constitutes a Home Coronavirus Test"3 minute read
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
- Media CoverageJames Boiani Quoted in "What's Next for the Post-Gottlieb FDA"3 minute read
- Media CoverageJames Boiani Quoted in "Lawyers: FDA's CLIA Waiver Guidances Give Industry More Flexibility"2 minute read
- BlogsThe SUPPORT for Patients and Communities Act: President Trump Signs Sweeping Opioid Law2 minute read
- Media CoverageJames Boiani Quoted in "The Ins and Outs of Lab-Developed Tests"4 minute read
- Media CoverageJames Boiani Quoted in "Device Lawyer: FDA Guidances Provide Clarity on Payer Communication"2 minute read
- Media CoverageJames Boiani Quoted in "FDA Wants to Ease Diagnostic/Drug Combo Study Paperwork"2 minute read
- Media CoverageJames Boiani Quoted in "Nicotine Replacement Trials and the App Effect"3 minute read
- Media CoverageJames Boiani Quoted in "What Hospitals Need To Know Before Forming A Drug Co."2 minute read
- Media CoverageJames Boiani Quoted in "Labs Hopeful for Less Severe Penalties for Referral Mishaps"2 minute read
- Media CoverageJames Boiani Quoted in "Life Sciences Regulation to Watch in 2018"3 minute read
- Media CoverageJames Boiani Quoted in "FDA Final Guidance on Drug/Device Classifications Misses the Mark, Attorneys Say"2 minute read