Nate Beaton advises clients on regulatory, transactional, litigation, and legislative matters involving the US Food and Drug Administration (FDA) and other regulatory authorities with jurisdiction over healthcare and biotechnology.

Nate leverages his broad understanding of the regulatory landscape and sophisticated industry knowledge to serve as a trusted advisor for:

• Pharmaceutical, biological product, human cellular and tissue product, and medical device manufacturers
• Digital health companies
• Clinical laboratories and in vitro diagnostics manufacturers
• Contract development and manufacturing organizations
• Food, dietary supplement, cosmetic, cannabidiol, and tobacco product manufacturers
• Trade associations
• Investors and lenders with interests in the healthcare and life sciences industry

He guides clients on complex regulatory issues, as well as legislation and rulemaking. Nate has been involved extensively in Administrative Procedure Act (APA) litigation, challenging and defending FDA actions and regulatory programs.

Nate helps clients evaluate regulatory risks and opportunities in the context of transactions in the healthcare and life sciences sectors.

A recognized thought leader, Nate frequently speaks and writes on healthcare and life sciences topics. He serves on the Food and Drug Law Journal’s editorial review board.

Thought Leadership

Nate’s recent publications and speaking engagements include:

• “Has the FDA Meaningfully Changed Its Restrictions on Off-Label Communications?,” Connected with Latham (December 2023)
• “FDA to Address Proposed Rule to Subject Laboratory-Developed Tests to Agency Oversight in Public Webinar,” Latham Client Alert (October 2023)
• “Shooting for the Moon: The Evolution of Key AI/ML Regulations Governing Certain Healthcare Products and Services,” Health Law Connections (August 2023)
• “FDA Publishes Proposed Rule for Tobacco Product Manufacturing Practice Requirements,” Latham Client Alert (April 2023)
• “FDA Omnibus Reform Act: Examining the Policy Changes,” Latham Client Alert (January 2023)
• “Food and Drug Omnibus Reform Act Introduces Key Changes to FDA’s Authorities,” Latham Client Alert (December 2022)
• “Continuing Appropriations Act Includes FDA Reauthorization of User Fees,” Latham Client Alert (October 2022)
• "Regulation of Biological Product Marketing,” Food and Drug Law Institute (October 2022)
• “The New Drug Approval Process,” Food and Drug Law Institute (April 2022)
• "Healthcare & Life Sciences: Who Is the New FDA Commissioner and What Are His Priorities?,” Connected with Latham (February 2022)