Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments

摘要

The Food and Drug Administration (FDA) has established a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of products posted between April 2, 2018, and September 14, 2018, on FDA's website but not presented at the September 20, 2018, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.