FDA Establishes Public Docket for Post-Marketing Pediatric-Focused Product Safety Reviews

Summary

The Food and Drug Administration (FDA) is launching a public review process for post-marketing safety reviews of pediatric-focused products, seeking comments from the public, academic researchers, and industry stakeholders on products reviewed between September 2, 2020, and September 2, 2021, but not discussed at the September 17, 2021, Pediatric Advisory Committee (PAC) meeting.