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Nathan Beaton assists clients with regulatory, transactional, litigation, and legislative matters involving the Food and Drug Administration (FDA) and other regulatory authorities with jurisdiction over healthcare and biotechnology. He helps clients in the pharmaceutical, biotechnology, medical device, and other FDA-regulated industries navigate all stages of the product life cycle, including:
- Pre-market regulatory interactions
- Clinical trials and pre-clinical testing
- Product submissions
- Non-patent exclusivity
- Good manufacturing practice
- Promotion and labeling
- Inspections and recalls
- Post-market regulatory interactions and appeals
Mr. Beaton counsels clients on legislation and rulemaking, such as matters relating to the Agriculture Improvement Act of 2018, FDA Reauthorization Act of 2017, 21st Century Cures Act, and Family Smoking Prevention and Tobacco Control Act of 2009. He has been involved extensively in Administrative Procedure Act litigation related to FDA actions and regulatory programs.
His experience extends to matters involving multiple regulatory bodies, including the Drug Enforcement Administration (DEA), US Department of Health and Human Services Office of Inspector General (HHS-OIG), US Department of Agriculture (USDA), and Federal Trade Commission (FTC).
He also regularly advises the regulatory aspects of mergers and acquisitions, equity offerings, financings, and other transactions in the life sciences sector.
A recognized thought leader, Mr. Beaton is a member of the Food and Drug Law Journal’s editorial advisory board and recently co-authored a chapter in A Practical Guide to FDA’s Food and Drug Law and Regulation (7th ed.).
Mr. Beaton’s recent publications and speaking engagements include:
- “The New Drug Approval Process,” Food and Drug Law Institute (April 2022)
- “Origins and Overview of FDA and the Regulation of Drugs,” Food and Drug Law Institute (November 2021)
- “Regenerative Medicine and Advanced Therapies,” Food and Drug Law Institute (October 2021)
- “The TCA and the Deeming Regulation,” Food and Drug Law Institute (November 2020)
- “Overview of Drug Law and Regulation,” Food and Drug Law Institute (November 2020)
- “FDA’s Regulatory Processes,” Food and Drug Law Institute (August 2020)