The Comment Period

Gardner Law

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. 6d ago

    E3: Move Fast and Get Clearance

    In Episode 3 of The Comment Period, Mark Gardner, Amanda Johnston, and Nathan Downing look at what happens when fast-moving technologies and markets collide with FDA regulation. The conversation covers wearables moving deeper into healthcare, the evolving GLP-1 compounding and peptide market, and the challenge of regulating generative AI-enabled medical devices. They also discuss emerging cancer treatments, personalized medicine, and the FDA programs that can help promising products reach patients faster.

    E3: Move Fast and Get Clearance

  2. Aug 19

    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.

  3. 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
  • 3 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
    3
  • Rating
    Clean
  • Copyright
    © 2026 Gardner Law
  • Show Website
    The Comment Period