Document

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

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 betw...

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 October 23, 2017, and March 16, 2018, on FDA's website but not presented at the March 23, 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.

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

83 FR 9324

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments,” thefederalregister.org (March 5, 2018), https://thefederalregister.org/documents/2018-04400/post-marketing-pediatric-focused-product-safety-reviews-establishment-of-a-public-docket-request-for-comments.