The Comment Period

Gardner Law
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Gardner Law attorneys Mark Gardner, Amanda Johnston, and Nathan Downing lead practical, timely conversations about the legal and business issues shaping FDA-regulated industries, including regulatory strategy, compliance, enforcement, litigation, privacy, AI, clinical trials, advertising, and other emerging developments.

Episodes

  1. 19h ago

    E2: The Code Never Bothered Me Anyway: Elsa, Sunshine, and a Little RAPID Fire

    Gardner Law attorneys Mark Gardner, Amanda Johnston, and Nathan Downing discuss several fast-moving developments affecting FDA-regulated companies, including FDA’s use of its ELSA AI tool in regulatory review, recent Sunshine Act enforcement, and changes to Medicare coverage pathways for breakthrough devices. The conversation also covers RAPID and NTAP, compounded peptides, the practical challenges of preparing submissions for an AI-assisted review environment, and what these policy shifts could mean for compliance, reimbursement, and commercialization.

  2. Jul 22

    E1: FDA in Flux

    In the debut episode of The Comment Period, Gardner Law attorneys examine how shifts in FDA leadership, policy, and enforcement are affecting FDA-regulated companies. The discussion covers direct-to-consumer advertising, AI at FDA, Whoop, peptides, digital health, and the practical challenges companies face when regulatory expectations are changing faster than the formal rules.

    E1: FDA in Flux
  • 2 Episodes

About

Gardner Law attorneys Mark Gardner, Amanda Johnston, and Nathan Downing lead practical, timely conversations about the legal and business issues shaping FDA-regulated industries, including regulatory strategy, compliance, enforcement, litigation, privacy, AI, clinical trials, advertising, and other emerging developments.

Information

  • Creator
    Gardner Law
  • Years Active
    2026
  • Episodes
    2
  • Rating
    Clean
  • Copyright
    © 2026 Gardner Law
  • Show Website
    The Comment Period