FDA Roundup: June 21, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published final guidance titled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection. This guidance defines the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of section 501(j) of the Federal Food Drug & Cosmetic Act. The examples used in this guidance are not intended to serve as an exhaustive list; rather, they illustrate the most common situations that FDA has encountered i...