Children's Health Defense Text Logo
CHD-TV Logo
X icon
Rumble Icon
DonateBecome an Insider
CHD-TV Logo
Home
EventsMoviesThe People's StudyArchiveGet AlertsContact UsSearch icon
CHD Logo

Children's Health Defense® is a 501(c)(3) non-profit organization. Our mission is ending childhood health epidemics by eliminating toxic exposure. We will restore and protect the health of children by eliminating environmental exposures, holding responsible parties accountable, and establishing safeguards to prevent future harm of children's health.  Protecting Children. Exposing Harms. Seeking Justice.

Substack Social Media Icon
Take Action
DonateJoin Our ListBecome an Insider

Donations are tax deductible to the full extent of the law. EIN #26-0388604

  • •Children's Health Defense
  • •Legal Disclaimer
  • •Terms of Use
  • •Privacy Policy
  • •Donate
  • •Work for CHD
  • •Contact
  • •Social

© 2016 - 2026 Children's Health Defense® • All Rights Reserved

Event Home

Sep 16, 2026

Sep 16, 2026

chat

FDA Pediatric Advisory Committee (PAC) Meeting | Sep. 16

*The opinions expressed by the hosts and guests in this show are not necessarily the views of Children’s Health Defense.

DonateJoin Our List

chat

Source: FDA

‘The PAC will have the opportunity to ask the Agency clarifying questions and to convey their recommendations for safety monitoring of the products listed below. The scope of the discussion will be limited to post-marketing safety and surveillance activities. No information is required from product sponsors.’

The PAC will meet to discuss the following products listed by FDA Center:

Center for Biologics Evaluation and Research

  • Epicel (cultured epidermal autografts) Humanitarian Device Exemption (HDE)
  • Quelimmune (HDE)

Center for Devices and Radiological Health

  • Enterra Therapy System (Humanitarian Device Exemption (HDE))
  • Liposorber LA-15 System (HDE)
  • Medtronic Activa Neurostimulator for Dystonia Treatment (HDE)
  • Medtronic Contegra Pulmonary Valved Conduit (HDE)
  • Minimally Invasive Deformity Correction (MID-C) System (HDE)
  • nAbCyte Anti-AAVRh74var HB-FE Assay (HDE)
  • Pleximmune (HDE)
  • Reflect Scoliosis Correction System (HDE)
  • Sonalleve MR-HIFU (HDE)
  • The Tether – Vertebral Body Tethering System (HDE)

Center for Drug Evaluation and Research

  • Aranesp (darbepoetin alfa)Dalvance (dalbavancin)
  • Fragmin (dalteparin sodium)
  • Isopto Atropine (atropine sulfate)
  • Kloxxado nasal spray, Zimhi injection, Naloxone Hydrochloride Autoinjector, Naloxone hydrochloride nasal spray, RiVive nasal spray, Rezenopy nasal spray (naloxone hydrochloride)
  • Lymphoseek (technetium Tc 99m tilmanocept)
  • Nextstellis (drospirenone/estetrol)
  • Sprycel (dasatinib)
  • Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate, magnesium sulfate)
  • Tecentriq (atezolizumab)
  • Veklury (remdesivir)
  • Vemlidy (tenofovir alafenamide)
  • Zelsuvmi (berdazimer)
  • Zevtera (ceftobiprole medocaril sodium)
  • Zinplava (bezlotoxumab)

Related Videos

FDA Pediatric Advisory Committee (PAC) Meeting | Nov. 13

FDA Pediatric Advisory Committee (PAC) Meeting | Nov. 13

FDA Pediatric Advisory Committee (PAC) Meeting | July 9

FDA Pediatric Advisory Committee (PAC) Meeting | July 9

FDA VRBPAC Meeting | January 26th, 2023

FDA VRBPAC Meeting | January 26th, 2023

FDA VRBPAC Meeting | Influenza Vaccines, Avian Flu + Research Program Updates | Oct. 10

FDA VRBPAC Meeting | Influenza Vaccines, Avian Flu + Research Program Updates | Oct. 10

Login