The Comment Period, Ep. 2: The Code Never Bothered Me Anyway

The second episode of the Gardner Law Podcast, The Comment Period, "The Code Never Bothered Me Anyway: Elsa, Sunshine, and a Little RAPID Fire," is now live. Each episode will feature practical, timely conversations about the legal and business issues shaping FDA-regulated industries. 

Episode 2 covers FDA’s use of its Elsa AI tool in regulatory review, recent Sunshine Act enforcement, the evolving RAPID and NTAP pathways for breakthrough devices, emerging policy on compounded peptides, and what these developments mean for FDA-regulated companies navigating compliance, submissions, reimbursement, and commercialization.

Watch below, or listen and subscribe on Spotify, YouTube, or Apple Podcasts.