Biography
Nicholas “Nick” Diamond is a regulatory lawyer with extensive, international experience counseling clients across the food, healthcare, life sciences, medical device, and technology sectors. While his practice primarily focuses on compliance counseling, he also has experience in global policy advocacy, commercial transactions, enforcement actions and investigations, and ethics and governance.
In the United States, Nick provides comprehensive counsel for entities and products regulated by the U.S. Food and Drug Administration (FDA). He has experience counseling clients on matters falling under FDA’s jurisdiction, such as: animal and veterinary products, including animal drugs and drug compounding; cosmetics; food (both human and animal), beverage, and dietary supplements; human pharmaceuticals and biotechnology products, spanning all therapeutic areas; medical devices (especially software-as-a-medical-device) and diagnostics; and vaccines. He also provides compliance counsel on federal laws impacting other healthcare-related entities, including clinical laboratories, clinical research institutions, digital health companies, and healthcare providers (including pharmacies).
Globally, Nick provides comprehensive counsel for life sciences, medical device, and other healthcare-related entities operating in ex-U.S. markets. He has experience supporting clients in Canada, across the Asia-Pacific region, the European Union and United Kingdom, Latin America, and the Middle East. In particular, he provides counsel on regulatory and transactional matters for new market entry, including both ex-U.S. companies entering the U.S. market and U.S. companies entering new markets abroad.
Nick also counsels clients on adjacent global and domestic compliance matters impacting their commercial operations, including anti-corruption laws (e.g., FCPA); artificial intelligence and machine learning regulation; business and human rights-related laws and international guidelines (e.g., UNGPs); data privacy and security laws (e.g., EU GDPR); international investment law; and WTO law (e.g., TRIPS).
Outside of his practice, Nick serves as an adjunct professor of law at the Georgetown University Law Center and the University of Houston Law Center, among other academic affiliations. He is widely published internationally on issues relating to his practice. His writing has been published in law reviews, peer-reviewed journals, and major media outlets, as well as discussed or featured in major media outlets, including The Washington Post and Forbes. He has given invited talks in various academic and industry fora, and has frequently appeared as a commentator on national news networks, such as Bloomberg and MSNBC.
Nick joined Jackson Walker LLP from a global law firm, where he concentrated on regulatory and public policy matters, and served as a senior leader in the firm’s global advisory affiliate.
Education
A.B., Georgetown University
J.D., Charleston School of Law
M.B.E., Perelman School of Medicine at the University of Pennsylvania
LL.M., Georgetown University Law Center, with honors
Bar Admissions
Washington, D.C.
- Counseled health system on FDA compliance and enforcement matters relating to its in-house medical software development program (US FDA law / software)
- Counseled medical publisher on FDA compliance and enforcement matters relating to its software products (US FDA law / software)
- Counseled cosmetics company on its contractual agreements for formulation development and product manufacturing (US FDA law / cosmetics)
- Counseled food company on FDA compliance matters regarding product marking and promotion (US FDA law / human food)
- Counseled food company on FDA compliance matters regarding a voluntary recall (US FDA 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 (US FDA law / dietary supplements)
- Counseled medical company specializing in fertility on its acquisition of a fertility clinic and laboratory (US 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 (US FDA law / enforcement)
- Counseled global medical device company specializing in proton therapy systems on FDA compliance matters relating to a proposed M&A transaction (US FDA law / device)
- Counseled warehousing and fulfillment company on FDA compliance requirements regarding holding and distributing medical devices (US FDA law / device)
- Counseled a drone delivery company on FDA compliance matters relating to over-the-counter drugs (US FDA law / OTC drugs)
- Counseled global medical device company specializing in neonatal and perinatal products on its acquisition of another global medical device company (US FDA law / device, US law / FCPA, EU law / device, EU law / GDPR)
- Counseled warehousing and fulfillment company on animal food compliance matters (US FDA law / animal food)
- Counseled veterinary telemedicine company on FDA compliance matters relating to extra-label drug use in animals (US FDA law / animal drug)
- Counseled warehousing and fulfillment company on animal drug compliance matters (US FDA law / animal drug)
- Counseled veterinary pharmacy company on FDA compliance matters relating to animal drug compounding (US FDA law / animal drug compounding)
- Counseled veterinary pharmacy company on marketing compliance matters (US FTC law / marketing)
- Counseled veterinary pharmacy company on prescribing and operations matters (US law / pharmacy)
- 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-US operations (EU law / data privacy)
- Negotiated clinical trial agreements for an investigator and research institution (investigational drug) (US FDA law / clinical trials)
- Negotiated clinical trial agreements for an investigator and research institution (investigational device) (US FDA law / clinical trials)
- Drafted clinical trial privacy authorization for an investigator and research institution (US FDA law / US privacy law / clinical trials)
- Counseled clinical trial investigator on how to respond to a serious adverse event involving the study drug (US FDA law / clinical trials)
Speeches & Presentations
- Speaker, “Nuts & Bolts of Regulation and Licensure Strategy,” National Vaccine Law Conference (September 2023)
- Moderator, “Achieving Equitable Global Access to Vaccines,” National Vaccine Law Conference (September 2023)
- Speaker, “Accelerating vaccine development timelines with experience, expertise and automation,” Bioanalysis Zone Webinar (September 2022)
- Speaker, “The Bright Future of Vaccine Development,” National Vaccine Law Conference (September 2022)
- Speaker, “International Vaccine Law,” National Vaccine Law Conference (September 2022)
- Guest, “How the Inflation Reduction Act Changes Tax and Healthcare Laws,” Jackson Walker Fast Takes Podcast (August 2022)
- Moderator, “Vaccine Innovation and the Future of Life-Course Immunization,” BIO International Convention (June 2022)
- Presenter, “FDA Enforcement and Regulatory Trends: What’s Ahead in 2022?,” Crowell & Moring Webinar (May 2022)
- “Global Vaccine Policy During the COVID-19 Pandemic,” University of Houston Law Center Health Law & Policy Institute 2021-22 Speaker Series (November 2021)
- Session Chair, “Key Considerations in Utilizing Real World Evidence for Regulatory Decisions,” DIADIA-CoRE Singapore Annual Meeting 2021 Panel Discussion (July 2021)
- Podcast Speaker, “The Pandemic Economy,” The Untold Stories of American Healthcare by the Nashville Healthcare Council (May 2021)
- Presenter, “FDA and the Response to COVID: Lessons Learned, and Where the Agency Goes From Here,” Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era (February 2021)
- Presenter, “Telehealth and Remote Monitoring: Requirements, Reimbursement, FDA Oversight, and Risks,” Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era (February 2021)
- Speaker, “Looming Challenges of COVID-19 Immunization: Progress and Gaps,” Network for Excellence in Health Innovation (NEHI) Looming Challenges of COVID-19 Immunization Summit Series (November 2020)
Publications
- Author, “Preparing for Compliance With the Modernization of Cosmetics Regulation Act,” Bloomberg Law (August 2023)
- Author, “FDA Trends Show Compliance Priorities For Supplement Cos.,” Law360 (July 2023)
- Author, “Mid-Year FDA Update: What’s New for Dietary Supplements?,” Jackson Walker Insights (June 2023)
- Co-Author, “Key Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements,” Jackson Walker Insights (April 2023)
- Author, “How Cos. Can Adapt To Global AI Regulation Trends,” Law360 (September 2022)
- Author, “Supply Chain Due Diligence Requirements for Certain Companies Doing Business in Germany Soon to Go Into Effect,” Jackson Walker Insights (September 2022)
- Author, “Next Steps for Healthcare and the Inflation Reduction Act,” Jackson Walker Insights (August 2022)
- Author, “Digital Health Implications of Recent HHS Anti-Discrimination Proposed Rule,” Jackson Walker Insights (August 2022)
- Author, “FDA Releases Draft Guidance on Remote Regulatory Assessments,” Jackson Walker Insights (July 2022)
- Co-Author, Güriş Construction & Engineering, Inc. v. Syrian Arab Republic (Int’l Comm. Arb.) (with Kabir A.N. Duggal), International Legal Materials (June 2022)
- Author, “FDA Finalizes Guidance on Combination Products,” Crowell & Moring’s Health Law Blog (February 2022)
- Co-Author, “2021 in Review: Continued Movement at the Intersection of International Arbitration and Human Rights,” Kluwer Arbitration Blog (January 2022)
- Co-Author, “Regime Interaction in Investment Arbitration: Crowded Streets; Are Human Rights Law and International Investment Law Good Neighbors?” Kluwer Arbitration Blog (January 2022)
- Author, “The State of FDA Regulation of Software as a Medical Device,” Law360 (January 2022)
- Co-Author, “Biopharma And Medical Device Trends Investors Should Watch In 2022,” MedTech Intelligence (November 2021)
- Author, “Inter-regime conversations: What barriers persist for individuals in international law?” Leiden Journal of International Law (October 2021)
- Co-Author, “Advancing Health Innovation in 2022: Where Should We Focus?” PharmExec.com (August 2021)
- Co-Author, “Model Investment Agreements and Human Rights: What Can We Learn from Recent Efforts?” Columbia Journal of Transnational Law (August 2021)
- Author, “Adapting Human Rights Due Diligence For Renewable Energy—Key Points,” Bloomberg Law (July 2021)
- Co-Author, “Procedural versus Substantive Reforms: Is the Work of UNCITRAL WGIII Worth the Wait?” Kluwer Arbitration Blog (June 2021)
- Co-Author, “Is Your Data Supply Chain Ethical? Don’t Restrict Due Diligence to Physical Operations.” Corporate Compliance Insights (June 15, 2021)
- Co-Author, “Vaccine Passport Success Rests on True Privacy, Equity, Security,” Bloomberg Law (May 2021)
- Co-Author, “Adding New Ingredients to an Old Recipe: Do ISDS Reforms and New Investment Treaties Support Human Rights?” Case Western Reserve Journal of International Law, Vol.53, Iss.1 (April 2021)
- Author, “The Impossibility of Noncontribution,” 61 VA. J. INT’L. L. ONLINE 175 (2021)
- Co-Author, “Human Rights and Investor–State Dispute Settlement Reform: Fitting a Square Peg into a Round Hole?” Journal of International Dispute Settlement (March 12, 2021)
- Author, “Developments in Investment and Human Rights in 2019,” Yearbook on International Investment Law & Policy 2020 (Lisa E. Sachs et al. eds., 2021)
- Co-Author, “2020 in Review: The Pandemic, Investment Treaty Arbitration, and Human Rights,” Kluwer Arbitration Blog (January 2021)
- Author “The Final Say on Australia’s Plain Packaging Law at the WTO,” O’Neill Institute for National & Global Health Law (August 2020)
- Co-Author, “ISDS Reform and Advancing All “Generations” of Human Rights,” Kluwer Arbitration Blog (June 2020)
- Author, “Necessity in the Time of Pandemics,” Georgetown Journal of International Law Blog (May 2020)
- Author, “Pandemics, Emergency Measures, and ISDS,” Kluwer Arbitration Blog (April 2020)
- Author, “2019 in Review: International Investment Agreements and Human Rights,” Kluwer Arbitration Blog (February 2020)
- Georgetown University Law Center, Adjunct Professor of Law
- University of Houston Law Center (UHLC), Adjunct Professor of Law
- UHLC Health Law & Policy Institute, Advisory Board Member
- Baylor College of Medicine’s Center for Medical Ethics and Health Policy, Health Policy Scholar
- University of Pennsylvania Center for Global Health, Associate Scholar
- Oxford University Press’ Investment Claims, Contributor
- Brill Research Perspectives in International Investment Law and Arbitration, Associate Editor
August 11, 2023
InsightsPreparing for Compliance With the Modernization of Cosmetics Regulation Act l Bloomberg Law
By Nicholas J. Diamond
Passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) at the end of 2022 was a watershed moment in the regulation of cosmetics. MoCRA represents a significant expansion of the US Food and Drug Administration’s (FDA) authority over cosmetics, including new requirements directly affecting cosmetic companies and their products.
Copyright 2023 Bloomberg Industry Group, Inc. (800-372-1033) Reproduced with permission.
August 9, 2023
PodcastsNick Diamond on Increased Transparency for Cosmetics Industry
JW Fast Takes Podcast | ~7.5 minutes
Congress in late 2022 largely expanded the U.S. Food and Drug Administration’s authority to regulate cosmetics companies. In this episode, Nick Diamond discusses key provisions of the Modernization of Cosmetics Regulation Act and what the new law means for the cosmetics industry and consumers.
July 10, 2023
InsightsFDA Trends Show Compliance Priorities For Supplement Cos. I Law360 (Subscription Required)
By Nicholas J. Diamond
In March, the FDA launched the new Dietary Supplement Ingredient Directory. The directory is intended to be a resource to help consumers, manufacturers and retailers quickly find relevant FDA materials, federal regulations and FDA enforcement actions — e.g., warning letters — for specific dietary ingredients.
June 23, 2023
InsightsMid-Year FDA Update: What’s New for Dietary Supplements?
By Nicholas J. Diamond
The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in those tablets). More specifically, FDA regulates the manufacturing, labeling, marketing, holding, and distribution of dietary supplements. As we settle into the summer, what were some key FDA developments for dietary supplements in the first half of 2023?
April 25, 2023
InsightsKey Considerations for Clinical Investigators When Negotiating Clinical Trial Agreements
By Nicholas J. Diamond and Taylor McDowell
Clinical trials are an essential component of the research architecture for developing new drugs and devices. Research institutions and their clinical investigators play an important role in supporting drug and device manufacturers—the clinical trial sponsors—in developing the data and evidence required to support regulatory submissions.
September 30, 2022
InsightsHow Cos. Can Adapt to Global AI Regulation Trends | Law360
By Nicholas Diamond | Regulators globally are exploring new regulatory regimes for artificial intelligence with activities continuing to ramp up since last year.
September 15, 2022
Speaking EngagementsNick Diamond Speaks on Vaccine Development at National Vaccine Law Conference
Nick Diamond presented two sessions at the National Vaccine Law Conference held at George Mason University’s Antonin Scalia Law School. The first session, “International Vaccine Law,” covered international structures for the development, regulation, and distribution of vaccines. The second session, “The Bright Future of Vaccine Development,” discusses regulatory issues for the collective pipeline.
September 9, 2022
InsightsSupply Chain Due Diligence Requirements for Certain Companies Doing Business in Germany Soon to Go Into Effect
By Nicholas J. Diamond & Manny Schoenhuber | On January 1, 2023, the so-called Supply Chain Due Diligence Act (Lieferkettensorgfaltspflichtengesetz) (the “Act”) will go into effect in Germany. Many companies doing business in Germany will need to ready their compliance operations in the coming months. The Act is also part of a broader trend in the European Union (EU) towards establishing mandatory human rights and environmental due diligence requirements, particularly for supply chain operations.
August 18, 2022
PodcastsHow the Inflation Reduction Act Changes Tax and Healthcare Laws
~11.5 minutes | Featuring Nick Diamond & Ashley Withers
With the Inflation Reduction Act of 2022 now signed into law, there are a number of changes to federal tax and healthcare laws. Nick Diamond and Ashley Withers join Jackson Walker’s Fast Takes podcast for a brief overview of key changes to taxes and healthcare under the new law.
August 18, 2022
InsightsNext Steps for Healthcare and the Inflation Reduction Act
By Nicholas J. Diamond
The Inflation Reduction Act of 2022 has been signed into law. This article explores key healthcare provisions in the IRA, including prescription drug pricing, inflationary rebates, Medicare Part D benefit resign provisions, and vaccine coverage.
- “Why Wind And Solar Companies Need To Address Human Rights,” Energy Monitor (February 2022)
- “With FDA Approval Of First COVID-19 Vaccine, Let The Mandates Begin: US Military, Disney World, CVS Health And More,” USA Today (August 2021)
- “Speed Bumps Ahead For IP Waiver But Will It Nudge Voluntary Licensing?“ Scrip Intelligence/Pink Sheet (May 2021)
- “Vaccine Passport Plans Can’t Ignore Web Of Privacy Laws,” Law360 (April 2021)
- Guest on Bloomberg TV’s Bloomberg Markets (April 13, 2020)
- Guest on Bloomberg TV’s Balance of Power with David Westin (04/13/2020) (April 2020)
- “COVID-19 Legal Issues,” Bloomberg Law with June Grasso (March 17, 2020)
- “Legal Issues Around the COVID-19 Pandemic,” Bloomberg Law with June Grasso (March 10, 2020)
- Guest on Bloomberg TV’s Balance of Power with David Westin (03/05/2020) (see 35:48) (March 2020)
- Guest on MSNBC’s NewsNation with Tamron Hall, “Punishment for Non-Vaxxers?” (2014)