Profile
As a nationally-recognized member of Greenberg Traurig’s FDA regulatory team, Nick Diamond focuses his practice exclusively on federal and international legal matters for businesses and products regulated by the U.S. Food and Drug Administration (FDA), and similar regulators in other major international markets.
Nick’s regulatory practice spans research, commercialization, post-market compliance, marketing and promotion, and enforcement across all FDA-regulated products, with a primary focus on drugs, devices, and diagnostics (including digital health products). He regularly counsels clients on “high-stakes” interactions with FDA, especially involving enforcement actions. His background as a trained bioethicist, combined with his experience teaching bioethics at leading academic institutions, enhances his ability to assist companies with ethical considerations that can emerge during research and product commercialization. His international regulatory practice is enhanced by his training in public international law, and includes in-depth experience navigating life sciences and medical device issues in Canada, the Asia-Pacific, the European Union and the United Kingdom, Latin America, and the Middle East.
Nick also applies his deep federal and international regulatory experience in the context of due diligence exercises for complex domestic and cross-border corporate transactions, especially for private equity sponsors. He has led the FDA regulatory due diligence on M&A transactions with transaction values ranging from a few million dollars to over $4 billion.
Apart from his practice, Nick is a passionate educator. Since 2018, he has taught as an adjunct professor at the Georgetown University Law Center. He is also an accomplished writer whose work has been featured in leading law reviews, scholarly journals, and well-respected media publications worldwide.
업무 분야]
주요 경력
- Counseled health system on FDA compliance and enforcement matters relating to its in-house medical software development program (U.S. FDA law/software).°
- Counseled medical publisher on FDA compliance and enforcement matters relating to its software products (U.S. FDA law/software).°
- Counseled cosmetics company on its contractual agreements for formulation development and product manufacturing (U.S. FDA law/cosmetics).°
- Counseled food company on FDA compliance matters regarding product marking and promotion (U.S. FDA law/human food).°
- Counseled food company on FDA compliance matters regarding a voluntary recall (U.S. FDA law/human food).°
- Counseled food company on FDA and USDA compliance and contractual matters applying to its vendor relationships (U.S. FDA law/USDA law/human food).°
- Counseled warehousing and fulfillment company on FDA compliance requirements regarding dietary supplements and conducted a compliance training on dietary supplement current good manufacturing practices for a large, cross-functional team (U.S. FDA law/dietary supplements).°
- Counseled medical company specializing in fertility on its acquisition of a fertility clinic and laboratory (U.S. FDA law/human cells, tissue, and cellular and tissue-based products).°
- Counseled global packaging company on FDA compliance and enforcement risks associated with a proposed acquisition (U.S. FDA law/enforcement).°
- Counseled global medical device company specializing in proton therapy systems on FDA compliance matters relating to a proposed M&A transaction (U.S. FDA law/device).°
- Counseled warehousing and fulfillment company on FDA compliance requirements regarding holding and distributing medical devices (U.S. FDA law/device).°
- Counseled industrial manufacturer on FDA device compliance requirements for new product development, labeling, and marketing (U.S. FDA law/device).°
- Counseled physician-entrepreneur on FDA device compliance requirements for new product development, labeling, and marketing (U.S. FDA law/device).°
- Counseled medical device company on how to respond to an Untitled Letter from FDA (U.S. FDA law/device).°
- Counseled medical device company on FDA regulatory requirements impacting a potential change to an existing product’s 510(k) clearance (U.S. FDA law/device).°
- Counseled a drone delivery company on FDA compliance matters relating to over-the-counter and prescription drugs (U.S. FDA law/human drugs).°
- Counseled global medical device company specializing in neonatal and perinatal products on its acquisition of another global medical device company (U.S. FDA law/device, U.S. law/FCPA, EU law/device, EU law/GDPR).°
- Counseled warehousing and fulfillment company on animal food compliance matters (U.S. FDA law/animal food).°
- Counseled veterinary telemedicine company on FDA compliance matters relating to extra-label drug use in animals (U.S. FDA law/animal drug).°
- Counseled warehousing and fulfillment company on animal drug compliance matters (U.S. FDA law/animal drug).°
- Counseled veterinary pharmacy company on FDA compliance matters relating to animal drug compounding (U.S. FDA law/animal drug compounding).°
- Counseled veterinary pharmacy company on marketing compliance matters (U.S. FTC law/marketing).°
- Counseled veterinary pharmacy company on prescribing and operations matters (U.S. law/pharmacy).°
- Counseled veterinary company on commercialization of new animal generic drugs (U.S. FDA law/new animal generic drugs).°
- Counseled veterinary company on commercialization of minor use/minor species new animal drugs (U.S. FDA law/minor use/minor species new animal drugs).°
- Counseled global medical device company on compliance with the proposed artificial intelligence-related regulations (EU law/AI).°
- Counseled global medical device company on compliance with the proposed data-related regulations (EU law/data governance).°
- Counseled global medical device company on device compliance matters under MDR and IVDR (EU law/device).°
- Counseled global trade association on COVID-19 vaccination and testing requirements for an international event (EU law/vaccines).°
- Counseled global trade association on EU GDPR requirements for its ex-U.S. operations (EU law/data privacy).°
- Negotiated clinical trial agreements for an investigator and research institution (investigational drug) (U.S. FDA law/clinical research).°
- Negotiated clinical trial agreements for an investigator and research institution (investigational device) (U.S. FDA law/clinical research).°
- Drafted clinical trial privacy authorization for an investigator and research institution (U.S. FDA law/U.S. privacy law/clinical research).°
- Counseled clinical trial investigator on how to respond to a serious adverse event involving the study drug (U.S. FDA law/clinical research).°
- Counseled clinical research institution on preparations for a FDA inspection (U.S. FDA law/clinical research).°
- Counseled clinical research institution on development of a response to a Form FDA 483 (U.S. FDA law/clinical research).°
- Counseled clinical research institution, with a global multisite footprint, on regulatory due diligence matters for a M&A transaction (U.S. FDA law/clinical research).°
- Drafted contractual agreements for 503A pharmacy services (U.S. FDA law/compounding pharmacies).°
- Drafted contractual agreements for 503B pharmacy services (U.S. FDA law/compounding pharmacies).°
- Counseled 503B pharmacy on wholesaling compliance under FDA guidance (U.S. FDA law/compounding pharmacies).°
- Counseled global retail platform on U.S. consumer product compliance requirements applying to its operations (U.S. CPSC law/U.S. FTC law/consumer products).°
- Counseled global retail platform on risk management strategies regarding fake or counterfeit goods (U.S. law/consumer products).°
- Counseled foreign entrepreneur on U.S. consumer product compliance and marketing requirements for U.S. market entry (U.S. CPSC law/U.S. FTC law/consumer products).°
°The above representations were handled by Mr. Diamond prior to his joining Greenberg Traurig, LLP.
- Adjunct Professor of Law, Georgetown University Law Center, 2017-Present
- Bioethics and Social Justice
- Public Health Law and Ethics
- Adjunct Professor of Law, University of Houston Law Center, 2021-Present
- Global Health Law
- Health Policy Scholar, Baylor College of Medicine, Center for Medical Ethics and Health Policy, 2021-Present
- Associate Scholar, Center for Global Health, Perelman School of Medicine at the University of Pennsylvania, 2017-Present
수상 및 주요 활동
- Listed, The Best Lawyers in America, Health Care Law, 2026
- Listed, The Legal 500 United States, Healthcare> Service Providers, 2025
- Member, FDLI’s Food and Drug Law Journal Editorial Advisory Board, 2025
- Advisory Board Member, University of Houston Law Center, Health Law & Policy Institute, 2021-Present
- Member, Personal Care Products Council (PCPC)
학력 및 자격사항
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LL.M., Global Health Law, with honors, Georgetown University Law Center
- Articles Editor, The Food and Drug Law Journal
- M.B.E., Bioethics, University of Pennsylvania Perelman School of Medicine
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J.D., Charleston School of Law
- Administrative Editor, Maritime Law Bulletin
- A.B., Georgetown University
- District of Columbia