Federal Register #FDA2026N7514

FDA Pediatric Advisory Committee Meeting: Review of Pediatric Biologics, Devices, and Pharmaceuticals

This opportunity involves a public advisory committee meeting organized by the Food and Drug Administration (FDA) under the Department of Health and Human Services. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Virtual public meeting of the Pediatric Advisory Committee (PAC) to discuss pediatric regulatory issues - Post-marketing pediatric-focused safety reviews of a wide range of products - OEMs and Vendors Mentioned: - Medtronic - Epicel (Vericel Corporation) - Pleximmune (Plexision Inc.) - Sonalleve MR-HIFU (Philips) - The Tether Vertebral Body Tethering System (Zimmer Biomet) - Aranesp (Amgen) - Dalvance (Allergan/AbbVie) - Fragmin (Pfizer) - Isopto Atropine (Alcon) - Kloxxado (Hikma Pharmaceuticals) - Zimhi (Adamis Pharmaceuticals) - RiVive (Harm Reduction Therapeutics) - Lymphoseek (Cardinal Health/Navidea Biopharmaceuticals) - Nextstellis (Mayne Pharma) - Sprycel (Bristol Myers Squibb) - Suprep Bowel Prep Kit (Braintree Laboratories/Ferring Pharmaceuticals) - Tecentriq (Genentech/Roche) - Veklury (Gilead Sciences) - Vemlidy (Gilead Sciences) - Zelsuvmi (Novan Inc.) - Zevtera (Basilea Pharmaceutica) - Zinplava (Merck) - Products/Services Discussed: - Biologics, medical devices, and pharmaceuticals for pediatric use - Specific products include Epicel, Quelimmune, Enterra Therapy System, Liposorber LA15 System, Medtronic Activa Neurostimulator, Medtronic Contegra Pulmonary Valved Conduit, MIDC System, nAbCyte Anti-AAVRh74var HBFE Assay, Pleximmune, Reflect Scoliosis Correction System, Sonalleve MRHIFU, The Tether Vertebral Body Tethering System, Aranesp, Dalvance, Fragmin, Isopto Atropine, Kloxxado nasal spray, Zimhi injection, Naloxone Hydrochloride Autoinjector, Naloxone hydrochloride nasal spray, RiVive nasal spray, Rezenopy nasal spray, Lymphoseek, Nextstellis, Sprycel, Suprep Bowel Prep Kit, Tecentriq, Veklury, Vemlidy, Zelsuvmi, Zevtera, and Zinplava - Notable Requirements: - No procurement or contract award is being announced - FDA is establishing a public docket for comments related to the meeting - The meeting is open to the public and will be held virtually

Description

The Food and Drug Administration (FDA) announces a public advisory committee meeting of the Pediatric Advisory Committee (PAC) to provide advice and recommendations on pediatric regulatory issues. The meeting will be held virtually on September 16, 2026, from 10:00 a.m. to 4:00 p.m. Eastern Time. FDA is establishing a docket for public comment on this document, with comments accepted until September 15, 2026. The meeting will include discussions on post-marketing pediatric-focused safety reviews of various products.

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