Cases
Experience: Representative Matters: Counseled health system on FDA compliance
enforcement matters relating to its in-house medical software development program (U.S. FDA law/software).
Counseled medical publisher on FDA compliance
enforcement matters relating to its software products (U.S. FDA law/software).
Counseled cosmetics company on its contractual agreements for formulation development
product manufacturing (U.S. FDA law/cosmetics).
Counseled food company on FDA compliance matters regarding product marking
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
USDA compliance
contractual matters applying to its vendor relationships (U.S. FDA law/USDA law/human food).
Counseled warehousing
fulfillment company on FDA compliance requirements regarding dietary supplements
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
laboratory (U.S. FDA law/human cells, tissue,
cellular
tissue-based products).
Counseled global packaging company on FDA compliance
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
fulfillment company on FDA compliance requirements regarding holding
distributing medical devices (U.S. FDA law/device).
Counseled industrial manufacturer on FDA device compliance requirements for new product development, labeling,
marketing (U.S. FDA law/device).
Counseled physician-entrepreneur on FDA device compliance requirements for new product development, labeling,
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
prescription drugs (U.S. FDA law/human drugs).
Counseled global medical device company specializing in neonatal
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
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
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
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
IVDR (EU law/device).
Counseled global trade association on COVID-19 vaccination
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
research institution (investigational drug) (U.S. FDA law/clinical research).
Negotiated clinical trial agreements for an investigator
research institution (investigational device) (U.S. FDA law/clinical research).
Drafted clinical trial privacy authorization for an investigator
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
marketing requirements for U.S. market entry (U.S. CPSC law/U.S. FTC law/consumer products).
The above representations were h
led by Mr. Diamond prior to his joining Greenberg Traurig, LLP.
Teaching
Scholarly Experience: Adjunct Professor of Law, Georgetown University Law Center, 2017-Present
Bioethics
Social Justice
Public Health Law
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
Health Policy, 2021-Present
Associate Scholar, Center for Global Health, Perelman School of Medicine at the University of Pennsylvania, 2017-Present