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

摘要

The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between April 12, 2019, and September 23, 2019, on FDA's website but not presented at the September 26 or 27, 2019, Joint Pediatric Advisory Committee (PAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee 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.