Nicholas J. Diamond

Experience: Representative Matters: 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.;; Teaching and Scholarly Experience: 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