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 In this section:

                Pediatric Advisory Committee

Pediatric Advisory Committee

                        2021 Meeting Materials, Pediatric Advisory Committee
          2023 Meeting Materials, Pediatric Advisory Committee
          Past Meeting Materials, Pediatric Advisory Committee
          Charter of the Pediatric Advisory Committee to the Food and Drug Administration
          Roster of the Pediatric Advisory Committee to the Food and Drug Administration Home
          Advisory Committees
          Committees and Meeting Materials
          Pediatric Advisory Committee
          Pediatric Advisory Recommendations and UpdatesPediatric Advisory Committee Pediatric Advisory Recommendations and Updates
  
  	
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    PrintThe Pediatric Advisory Committee (PAC) advises and makes recommendations to the FDA about matters involving pediatrics. One of the PAC’s responsibilities is to review, evaluate, and make recommendations on adverse event reports of post market pediatric safety data for certain medical products. The safety reviews enable the FDA to identify safety concerns in children that may not be possible to detect before the product is marketed. The PAC also advises on aspects of Humanitarian Device Exemptions (HDEs) for certain HDE devices that are approved in pediatric patients.

The spreadsheet below includes medical products that have been shared with the PAC as required by federal law, FDA’s safety review information and the PAC’s recommendations.

Product Name
			Safety Review
			Date PostedBaraclude (entecavir)
			Baraclude Safety and Utilization Review
			09/12/2016Isentress (raltegravir potassium)
			Isentress Safety and Utilization Review
			09/12/2016Lysteda (tranexamic acid)
			Lysteda Safety and Utilization Review
			09/12/2016Salonpas Relief (methyl salicylate 10% and 1-menthol 3%P Patch)
			Salonpas Relief Safety and Utilization Review
			09/12/2016Aleve PM® (naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg)
			Aleve PM® Safety and Utilization Review
			02/03/2017Astepro (azelastine hydrochloride)
			Astepro Safety and Utilization Review
			02/03/2017Jetrea® (ocriplasmin) Intravitreal Injection
			Jetrea® Safety and Utilization Review
			02/03/2017Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets, for oraluse)
			Quartette Safety and Utilization Review
			02/03/2017Spectazole (econazole nitrate) cream, 1% Ecoza (econazole nitrate) topical foam,1%
			Spectazole/Ecoza Safety and Utilization Review
			02/03/2017Truvada® (emtricitabine and tenofovir disoproxil fumarate)
			Truvada® Safety and Utilization Review
			02/03/2017Xerese® (5% acyclovir and 1% hydrocortisone cream)
			Xerese® Safety and Utilization Review
			02/03/2017Aloxi (palonosetron hydrochloride)
			Aloxi Safety and Utilization Review
			08/04/2017Arnuity Ellipta (fluticasone furoate)
			Arnuity  Ellipta Safety and Utilization Review
			08/04/2017Asmanex HFA  and Asmanex  Twisthaler (mometasone furoate inhalation)
			Asmanex HFA and Asmanex Twisthaler Safety and Utilization Review
			08/04/2017Cymbalta (duloxetine)
			Cymbalta Safety and Utilization Review
			08/04/2017Emsam (selegiline transdermal system)
			Emsam Safety and Utilization Review
			08/04/2017GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use
			GRASTEK Safety and Utilization ReviewFDA Drug Utilization Information on GRASTEK and ORALAIR
			08/04/2017Latisse® (bimatoprost ophthalmic solution) 0.03%
			Latisse® Safety and Utilization Review
			08/04/2017Namenda and Namenda XR extended-release (memantine hydrochloride)
			Namenda and Namenda XR Safety and Utilization Review
			08/04/2017ORALAIR (Sweet Vernal, Orchard Perennial rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for sublingual Use
			ORALAIR Safety and Utilization ReviewFDA Drug Utilization Information on GRASTEK and ORALAIR
			08/04/2017Priftin® (rifapentine)
			Priftin® Safety and Utilization Review
			08/04/2017Reyataz® (atazanavir)
			Reyataz® Safety and Utilization Review
			08/04/2017Taclonex (betamethasone dipropionate/calcipotriene hydrate) 0.064%/0.005%
			Taclonex Safety and Utilization Review
			08/04/2017Zetonna (ciclesonide)
			Zetonna (ciclesonide) Safety and Utilization Review
			08/04/2017Dymista (azelastine hydrochloride fluticasone propionate)
			Dymista (azelastine hydrochloride fluticasone propionate) Pediatric Safety Review
			01/07/2018Edurant (rilpivirine) Complera and Odefsey
			Edurant (rilpivirine) Complera and Odefsey Pediatric Safety Review
			01/07/2018Merrem IV (meropenem)
			Merrem IV (meropenem) Pediatric Safety Review
			01/07/2018Naftin (nafifine hydrochloride)
			Naftin (nafifine hydrochloride) Pediatric Safety and Drug Utilization Review
			01/07/2018OTIPRO (ciprofloxacin otic suspension)
			OTIPRO (ciprofloxacin otic suspension) Pediatric Safety Review
			01/07/2018PAZEO (olopatadine hydrochloride ophthalmic solution)
			PAZEO (olopatadine hydrochloride ophthalmic solution) Pediatric Safety Review
			01/07/2018QNASL beclomethasone dipropionate) nasal aerosol
			QNASL beclomethasone dipropionate) nasal aerosol Safety Review
			01/07/2018Treximet (naproxen sodium sumatriptan succinate)
			Treximet (naproxen sodium sumatriptan succinate) Safety Review
			01/07/2018Valcyte (valganciclovir)
			Valcyte (valganciclovir) Safety Review
			01/07/2018Atropine Sulfate Ophthalmic Solution, USP 1%
			Atropine Sulfate Ophthalmic Solution, USP 1% Pediatric Postmarketing Pharmacovigilance Review
			03/05/2018Emend (aprepitant) Capsule and Oral Suspension
			Emend (aprepitant) Capsule and Oral Suspension Pediatric Safety Review
			03/05/2018Epicel (cultured epidermal autografts)
			Epicel (cultured epidermal autografts) Executive Summary, Pediatric Safety Update
			03/05/2018Epiduo Forte (adapalene/benzoyl peroxide, 0.3%/2.5%) gel
			Epiduo Forte (adapalene/benzoyl peroxide, 0.3%/2.5%) gel Pediatric Safety Review
			03/05/2018Flourish Pediatric Esophageal Atresia Device
			Flourish 2018 Executive Summary
			03/05/2018Gadavist (gadobutrol), Eovist or Primovist (gadoxetate disodium)
			Gadavist (gadobutrol) Eovist or Primovist (gadoxetate disodium) Pediatric Safety Review
			03/05/2018Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
			Gardasil 9 Pediatric Safety and Utilization Review
			03/05/2018Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets
			Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets Pediatric Safety Review
			03/05/2018Kapvay (clonidine extended-release) tablets
			Kapvay® (clonidine extended-release) tablets Pediatric Safety and Drug Utilization Review
			03/05/2018Nucala (mepolizumab)
			Nucala (mepolizumab) Pediatric Safety Review
			03/05/2018Saphris (asenapine)
			Saphris (asenapine) Pediatric Safety Review
			03/05/2018Tivicay (dolutegravir)
			Tivicay (dolutegravir) Pediatric Safety Review
			03/05/2018Trumenba Meningococcal Group B Vaccine
			Trumenba Pediatric Pediatric Safety Review
			03/05/2018Banzel (rufinamide)
			Banzel (rufinamide) Pediatric Safety ReviewBanzel (rufinamide) Pediatric Utilization Review
			04/25/2018Liposorber LA-15 System
			Liposorber LA-15 System 2018 Executive Summary
			04/25/2018Medtronic Activa Dystonia Therapy
			Medtronic Activa Dystonia Therapy 2018 Executive Summary
			04/25/2018Adzenys XR and Dyanavel XR (amphetamine)
			Dyanavel Pediatric Safety Review
			06/13/2018Anthim (obiltoxaximab)
			Anthim Pediatric Safety Review
			06/13/2018Aptensio XR and Quillichew (methylphenidate hydrochloride)
			Aptensio XR and Quillichew ER Pediatric Safety Review
			06/13/2018Cinqair (reslizumab)
			Cinqair Pediatric Safety Review
			06/13/2018Cutivate (fluticasone propionate)
			Cutivate Pediatric Safety Review
			06/13/2018Descovy (emtricitabine and tenofovir alafenamide)
			Descovy Pediatric Safety Review
			06/13/2018Epivir (lamivudine)
			Epivir Pediatric Safety Review
			06/13/2018Kaletra (lopinavir and ritonavir)
			Kaletra Pediatric Safety Review
			06/13/2018Natroba (spinosad)
			Natroba Pediatric Safety Review
			06/13/2018Noxafil (posaconazole)
			Noxafil Pediatric Safety Review
			06/13/2018Oraltag (iohexol)
			Oraltag Pediatric Safety Review
			06/13/2018Otovel Otic Solution (ciprofloxacin and fluocinolone acetonide)
			Ovotel Pediatric Safety Review
			06/13/2018Prilosec (omeprazole)
			Prilosec Pediatric Safety Review
			06/13/2018ProAir RespiClick (abuterol sulfate)
			ProAir Respiclick Pediatric Safety Review
			06/13/2018Procysbi (cysteamine bitartrate)
			Procysbi Pediatric Safety Review
			06/13/2018Teflaro Injection (ceftaroline fosamil)
			Teflaro Pediatric Safety Review
			06/13/2018Tetracaine Hydrochloride Ophthalmic Solution (tetracaine hydrochloride)
			Tetracaine Pediatric Safety Review
			06/13/2018Xopenex HFA Inhalation Aerosol (levalbuterol)
			Xopenex Pediatric Safety Review
			06/13/2018Bexsero (Meningococcal Group B Vaccine)
			Bexsero Safety Review
			09/12/2018Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE])
			Contegra 2018 Executive Summary
			09/12/2018Elana Surgical Kit (HDE)
			Elana Surgical Kit 2018 Executive Summary
			09/12/2018Enterra Therapy System (HDE)
			Enterra 2018 Executive Summary
			09/12/2018Entocort EC (budesonide)
			Entocort EC Safety Review
			09/12/2018Epzicom (abacavir sulfate and lamivudine) and Ziagen (abacavir sulfate)
			Epzicom and Ziagen Safety Review
			09/12/2018Kovanaze (tetracaine HCl and oxymetazoline HCl)
			Kovanaze Safety Review
			09/12/2018Lamictal (lamotrigine)
			Lamictal Safety Review
			09/12/2018Oraverse (phentolamine mesylate)
			Oraverse Safety Review
			09/12/2018Pancreaze & Pertzye (pancrelipase)
			Pancreaze & Pertzye Safety Review
			09/12/2018PleximmuneTM in-vitro diagnostic test (HDE)
			PleximmuneTM2018 Executive Summary
			09/12/2018PulseRider Aneurysm Neck Reconstruction Device (HDE)
			PulseRider 2018 Executive Summary
			09/12/2018Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed andInactivated Poliovirus Vaccine)
			Quadracel Safety Review
			09/12/2018Renvela (sevelamer carbonate)
			Renvela Safety Review
			09/12/2018Zomig Nasal Spray (zolmitriptan)
			Zomig Nasal Spray Safety Review
			09/12/2018Aczone (dapsone) gel, 7.5%
			Aczone Safety Review
			03/28/2019Adynovate
			Adynovate Safety Review
			03/28/2019AirDuo RespiClick (fluticasone propionate and salmeterol xinafoate) ArmonAir RespiClick (fluticasone propionate)
			AirDuo Respiclick and ArmonAir Respiclick Safety Review
			03/28/2019Avelox (moxifloxacin, tablets and injection)
			Avelox Safety Review
			03/28/2019Caldolor (ibuprofen) IV injection
			Caldolor Safety Review
			03/28/2019Cubicin® and Cubicin® RF (daptomycin for injection)
			Cubicin Safety Review
			03/28/2019Dexilant, Dexilant SoluTab (dexlansoprazole)
			Dexilant Safety Review
			03/28/2019Epicel (cultured epidermal autografts)
			Epicel 2019 Executive Summary
			03/28/2019Eucrisa (crisaborole) ointment, 2%
			Eucrisa Safety Review
			03/28/2019FlourishTM Pediatric Esophageal Atresia Device
			Flourish 2019 Executive Summary
			03/28/2019IXINITY [Coagulation Factor IX (Recombinant)]
			IXINITY Safety Review
			03/28/2019Liletta (levonorgestrel-releasing intrauterine system)
			Liletta Safety Review
			03/28/2019Liposorber® LA-15 System
			Liposorber 2019 Executive Summary
			03/28/2019Lyrica (pregabalin)
			Lyrica Safety Review
			03/28/2019Medtronic Activa Neurostimulator for Dystonia Treatment
			Medtronic Activa 2019 Executive Summary
			03/28/2019Narcan (naloxone) nasal spray
			Narcan Safety Review
			03/28/2019Ofirmev (acetaminophen) injection
			Ofirmev Safety Review
			03/28/2019Selzentry (maraviroc)
			Selzentry Safety Review
			03/28/2019Spiriva Respimat (tiotropium bromide)
			Spiriva Safety Review
			03/28/2019Symbicort (budesonide/ formoterol fumarate dihydrate)
			Symbicort Safety Review
			03/28/2019TarcevaTM (erlotinib)
			Tarceva Safety Review
			03/28/2019Velcade® (bortezomib)
			Velcade Safety Review
			03/28/2019Ativan injection (lorazepam injection)
			Ativan Pediatric Safety Review
			09/19/2019Calcium gluconate injection (calcium gluconate)
			Calcium Gluconate Pediatric Safety Review
			09/19/2019Cerebyx® (fosphenytoin sodium)
			Cerebyx® Pediatric Safety Review
			09/19/2019Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE])
			Contegra 2019 Executive Summary
			09/19/2019Dotarem (gadoterate meglumine)
			Dotarem Pediatric Safety Review
			09/19/2019E-Z-HD (barium sulfate)
			Barium Sulfate Pediatric Safety Review
			09/19/2019Elana Surgical Kit (HDE)
			Elana Surgical Kit 2019 Executive Summary
			09/19/2019Enterra Therapy System (HDE)
			Enterra Therapy System 2019 Executive Summary
			09/19/2019Fycompa oral tablets and suspension (perampanel)
			Fycompa Pediatric Safety Review
			09/19/2019Gammaplex - Immune Globulin Intravenous (Human) 5% Liquid
			Gammaplex Safety and Utilization Review
			09/19/2019Harvoni (ledipasvir and sofosbuvir)
			Harvoni Pediatric Safety Review
			09/19/2019Isentress and Isentress HD (raltegravir)
			Isentress and Isentress HD Pediatric Safety Review
			09/19/2019Latuda (lurasidone hydrochloride)
			Latuda Pediatric Safety Review
			09/19/2019Liquid E-Z-Paque (barium sulfate)
			Barium Sulfate Pediatric Safety Review
			09/19/2019NUWIQ® (simoctocog alfa)
			NUWIQ® Safety and Utilization Review
			09/19/2019PleximmuneTM in-vitro diagnostic test (HDE)
			PleximmuneTM 2019 Executive Summary
			09/19/2019PulseRider Aneurysm Neck Reconstruction Device (HDE)
			PulseRider 2019 Executive Summary
			09/19/2019Rapivab® (peramivir)
			Rapivab® Pediatric Safety Review
			09/19/2019Readi-Cat 2, Readi-Cat 2 smoothies (barium sulfate)
			Barium Sulfate Pediatric Safety Review
			09/19/2019Ryzodeg 70/30 (insulin degludec and insulin aspart injection) for subcutaneous use 100 units/mL (U-100) in 3mL FlexTouch Pen
			Ryzodeg Pediatric Safety Review
			09/19/2019Simponi (golimumab SC), Simponi Aria (golimumab IV)
			Simponi Pediatric Safety Review
			09/19/2019Sovaldi (sofosbuvir)
			Sovaldi Pediatric Safety Review
			09/19/2019Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)
			Stribild Pediatric Safety Review
			09/19/2019TACHOSIL (Fibrin Sealant Patch)
			TACHOSIL Safety and Utilization Review
			09/19/2019Tresiba (insulin degludec injection) for subcutaneous use, 100 units/mL (U-100) in 3mL single-patient-use FlexTouch Pen; 200 units/mL (U-200) in 3mL single-patient-use FlexTouch Pen; 100 units/mL (U-100) 10 mL in multiple-dose vial
			Tresiba Pediatric Safety Review
			09/19/2019Varibar pudding (barium sulfate)
			Barium Sulfate Pediatric Safety Review
			09/19/2019Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5%)
			Vigamox Pediatric Safety Review
			09/19/2019Visipaque injection (iodixanol)
			Visipaque Pediatric Safety Review
			09/19/2019WILATE (von Willebrand Factor/ Coagulation Factor VIII Complex (Human))
			WILATE Safety and Utilization Review
			09/19/2019Zemplar (paricalcitol)
			Zemplar Pediatric Safety Review
			09/19/2019Zymar® 0.3% (gatifloxacin ophthalmic solution)
			Zymar® Pediatric Safety Review
			09/19/2019AFSTYLA (antihemophilic factor (recombinant), single chain)
			AFSTYLA Safety and Utilization Review
			07/13/2020Butrans (buprenorphine transdermal system)
			Butrans Pediatric Safety and Utilization Review
			07/13/2020DraxImage DTPA (technetium TC-99m pentetate kit) injection and inhalation
			DraxImage DTPA Pediatric Safety Review
			07/13/2020Dysport (AbobotulinumtoxinA)
			Dysport Pediatric Safety Review
			07/13/2020Epicel (cultured epidermal autografts)
			Epicel 2020 Executive Summary
			07/13/2020KOVALTRY (antihemophilic factor (recombinant))
			KOVALTRY Safety and Utilization Review
			07/13/2020Liposorber® LA-15 System (HDE)
			Liposorber® LA-15 System 2020 Executive Summary
			07/13/2020Lumason (sulfur hexafluoride lipid-type A microspheres) injectable suspension
			Lumason Pediatric Safety Review
			07/13/2020Medtronic Activa® Dystonia Therapy (HDE)
			Medtronic Activa® Dystonia Therapy 2020 Executive Summary
			07/13/2020Omidria (phenylephrine and ketorolac intraocular solution)
			Omidria Pediatric Safety Review
			07/13/2020Stelara (ustekinumab) injection
			Stelara Pediatric Safety Review
			07/13/2020Symfi LoTM (efavirenz 400mg + lamivudine 300mg + tenofovir disoproxil fumarate 300mg) and SymfiTM (efavirenz 600mg + lamivudine 300mg + tenofovir disoproxil fumarate 300mg)
			Symfi LoTM and SymfiTM Pediatric Safety Review
			07/13/2020Canasa (mesalamine suppositories for rectal use)
			Canasa Pediatric Safety Review
			09/01/2020Contegra Pulmonary Valved Conduit (HDE)
			Contegra Pulmonary Valved Conduit Executive Summary
			09/01/2020Descovy® (emtricitabine and tenofovir alafenamide)
			Descovy® Pediatric Safety Review
			09/01/2020Elana Surgical Kit (HDE)
			Elana Surgical Kit Executive Summary
			09/01/2020Enterra Therapy System (HDE)
			Enterra Therapy System Executive Summary
			09/01/2020Flucelvax (influenza vaccine)
			Flucelvax Safety and Utilization Review
			09/01/2020Flucelvax Quadrivalent (influenza vaccine)
			Flucelvax Quadrivalent Safety and Utilization Review
			09/01/2020FluLaval (influenza vaccine)
			FluLaval Safety and Utilization Review
			09/01/2020FluLaval Quadrivalent (influenza vaccine)
			FluLaval Quadrivalent Safety and Utilization Review
			09/01/2020Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir
			Genvoya® Pediatric Safety Review
			09/01/2020Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]
			Hiberix Safety and Utilization Review
			09/01/2020Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
			Influenza A (H5N1) Virus Monovalent Vaccine Safety and Utilization Review
			09/01/2020Lumify (brimonidine tartrate) OTC
			Lumify Pediatric Safety Review
			09/01/2020Luzu (luliconazole) cream, 1%
			Luzu Pediatric Safety Review
			09/01/2020PleximmuneTM in-vitro diagnostic test (HDE)
			PleximmuneTM in-vitro diagnostic test Executive Summary
			09/01/2020PulseRider Aneurysm Neck Reconstruction Device (HDE)
			PulseRider Aneurysm Neck Reconstruction Device Executive Summary
			09/01/2020Sensipar (cinacalcet)
			Sensipar Pediatric Safety Review
			09/01/2020Triumeq (abacavir, dolutegravir, and lamivudine)
			Triumeq Pediatric Safety Review
			09/01/2020Xepi (ozenoxacin)
			Xepi Pediatric Safety Review
			09/01/2020Aptiom (eslicarbazepine acetate)
			Aptiom Pediatric Postmarketing Pharmacovigilance Review
			04/26/2021Cotempla XR-ODT (methylphenidate extended release orally disintegrating tablets)
			Cotempla Pediatric Postmarketing Pharmacovigilance Review
			04/26/2021Cuvitru, Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution
			Cuvitru Safety and Utilization Review
			04/26/2021Epicel (cultured epidermal autografts)
			Epicel Safety Update
			04/26/2021JIVI (Antihemophilic Factor (Recombinant), PEGylated-aucl)
			JIVI Safety and Utilization Review
			04/26/2021Liposorber® LA-15 System
			Liposorber® LA-15 System Executive Summary
			04/26/2021Medtronic Activa® Dystonia Therapy (HDE)
			Medtronic Activa® Dystonia Therapy Executive Summary
			04/26/2021Minimally Invasive Deformity Correction (MID-C) System
			Minimally Invasive Deformity Correction (MID-C) System Executive Summary
			04/26/2021Pegasys (peginterferon alpha-2a)
			Pegasys Pediatric Postmarketing Pharmacovigiliance Review
			04/26/2021REBINYN (nonacog beta pegol (N9-GP))
			REBINYN Safety and Utilization Review
			04/26/2021The TetherTM – Vertebral Body Tethering System
			The TetherTM – Vertebral Body Tethering System Executive Summary
			04/26/2021Vimovo (naproxen/esomeprazole magnesium)
			Vimovo Pediatric Postmarketing Pharmacovigilance Review
			04/26/2021Cialis (tadalafil)
			Cialis Pediatric Postmarketing Pharmacovigilance Review
			09/03/2021Elana Surgical Kit (HDE)
			Elana Surgical Kit Executive Summary
			09/03/2021Emend (fosaprepitant dimeglumine)
			Emend Pediatric Postmarketing Pharmacovigilance Review
			09/03/2021Enbrel (etanercept), Erelzi (etanercept-szzs), Eticovo (etanercept-ykro)
			Enbrel Pediatric Postmarketing Pharmacovigilance Review
			09/03/2021Enterra Therapy System (HDE)
			Enterra Therapy System Executive Summary
			09/03/2021Fasenra (benralizumab)
			Fasenra Pediatric Postmarketing Pharmacovigilance Review
			09/03/2021Intelence (etravirine)
			Intelence Pediatric Postmarketing Pharmacovigilance Review
			09/03/2021Medtronic Contegra Pulmonary Valved Conduit (HDE)
			Medtronic Contegra Pulmonary Valved Conduit Executive Summary
			09/03/2021PleximmuneTM in-vitro diagnostic test (HDE)
			Pleximmune Executive Summary
			09/03/2021PulseRider Aneurysm Neck Reconstruction Device (HDE)
			PulseRider Aneurysm Neck Reconstruction Device Executive Summary
			09/03/2021RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)
			Rotateq Safety and Utilization Review
			09/03/2021Rubber Panel T.R.U.E. TEST (Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test)
			Rubber Panel T.R.U.E. TEST Safety and Utilization Review
			09/03/2021T.R.U.E. TEST (Thin-Layer Rapid Use Epicutaneous Patch Test)
			T.R.U.E. TEST Safety and Utilization Review
			09/03/2021Tekturna (aliskiren hemifumarate)
			Tekturna Pediatric Postmarketing Pharmacovigilance Review
			09/03/2021Viread (tenofovir disoproxil fumarate)
			Viread Pediatric Postmarketing Pharmacovigilance Review
			09/03/2021Xofluza (baloxavir marboxil)
			Xofluza Pediatric Postmarketing Pharmacovigilance Review
			09/03/2021Actemra (tocilizumab)
			Actemra Pediatric Postmarketing Pharmacoviligalance Review
			4/19/2022Activa Dystonia Therapy (none)
			Medtronic Activa Neurostimulator for Dystonia Treatment Executive Summary
			4/25/2022Amitiza (lubiprostone)
			Amitiza Pediatric Postmarketing Pharmacovigilance Review
			4/25/2022Epicel (cultured epidermal autografts)
			Epicel (cultured epidermal autografts) Safety Update Memorandum
			4/25/2022ESPEROCT (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
			ESPEROCT (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei) Safety Update Memorandum
			4/25/2022Liposorber LA-15 System (none)
			Liposorber LA-15 System Executive Summary
			4/25/2022Mavyret (glecaprevir/pibrentasvir)
			Mavyret (glecaprevir/pibrentasvir) Pediatric Postmarketing Pharmacovigilance Review
			4/25/2022Minimally Invasive Deformity Correction (MID-C) System (none)
			Minimally Invasive Deformity Correction (MID-C) System (none) Executive Summary
			4/25/2022PANZYGA (Immune Globulin Intravenous, human-ifas)
			PANZYGA (Immune Globulin Intravenous, human-ifas) Safety Update Memorandum
			4/25/2022Pristiq (desvenlafaxine)
			Pristiq (desvenlafaxine) Pediatric Postmarketing Pharmacovigilance Review
			4/25/2022Slynd (drospirenone)
			Slynd (drospirenone) Pediatric Postmarketing Pharmacovigilance Review
			4/25/2022The Tether - Vertebral Body Tethering System (none)
			The Tether - Vertebral Body Tethering System (none) Executive Summary
			4/25/2022Xembify(immune globulin subcutaneous, human – klhw)
			Xembify(immune globulin subcutaneous, human – klhw) Safety Update Memorandum
			4/25/2022Xolair (omalizumab)
			Xolair (omalizumab) Pediatric Postmarketing Pharmacovigilance Review
			4/25/2022Asceniv (Immune Globulin Intravenous (Human), 10% Liquid)
			Asceniv (Immune Globulin Intravenous (Human), 10% Liquid) Safety Update Memorandum
			8/18/2022Benlysta (belimumab)
			Benlysta (belimumab) Pediatric Postmarketing Pharmacovigilance Review
			8/18/2022Contegra (none)
			Medtronic Contegra Pulmonary Valved Circuit Models 200 and 200s Executive Summary
			8/18/2022Enterra Gastric Electrical Stimulator (none)
			Enterra Therapy System Executive Summary
			8/18/2022FIBRYGA (Fibrinogen (Human))
			FIBRYGA (Fibrinogen (Human)) Safety Update Memorandum
			8/18/2022Flourish Pediatric Esophageal Atresia Device (none)
			Flourish Pediatric Esophageal Atresia Device Executive Summary
			8/18/2022Pleximmune (none)
			Pleximmune Executive Summary
			8/18/2022PulseRider Aneurysm Neck Reconstruction Device (none)
			PulseRider Aneurysm Neck Reconstruction Device Executive Summary
			8/18/2022Sonalleve MR-HIFU (None)
			Sonalleve MR-HIFU Executive Summary
			8/18/2022Vfend (voriconazole)
			Vfend (voriconazole) Pediatric Postmarketing Pharmacovigilance Review
			8/18/2022Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))
			Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) Safety Update Memorandum
			8/18/2022Mavyret (glecaprevir/pibrentasvir)
			Mavyret (glecaprevir/pibrentasvir) Pediatric Postmarketing Pharmacovigilance Review
			9/22/2022Actemra (tocilizumab)
			Actemra (tocilizumab) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Actemra (tocilizumab)
			Actemra (tocilizumab) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Activa Dystonia Therapy (none)
			Activa Dystonia Therapy Executive Summary
			4/19/2023AFLURIA; AFLURIA QUADRIVALENT (Influenza Vaccine)
			AFLURIA; AFLURIA QUADRIVALENT (Influenza Vaccine) Safety Update Memorandum
			4/19/2023Altreno lotion (tretinoin)
			Altreno lotion (tretinoin) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Arnuity Ellipta (fluticasone furoate)
			Arnuity Ellipta (fluticasone furoate) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Astagraf XL (tacrolimus)
			Astagraf XL (tacrolimus) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Avycaz (ceftazidime/avibactam)
			Avycaz (ceftazidime/avibactam) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Botox(onabotulinumtoxinA)
			Botox(onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Botox(onabotulinumtoxinA)
			Botox(onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Botox(onabotulinumtoxinA)
			Botox(onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Botox injection (onabotulinumtoxinA)
			Botox injection (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Botox injection (onabotulinumtoxinA)
			Botox injection (onabotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Breo Ellipta (fluticasone furoate/vilanterol)
			Breo Ellipta (fluticasone furoate/vilanterol) Safety Update Memorandum
			4/19/2023Briviact (brivaracetam)
			Briviact (brivaracetam) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Briviact tablets, solution, and injection(brivaracetam)
			Briviact tablets, solution, and injection(brivaracetam) Safety Update Memorandum
			4/19/2023Clenpiq (sodium picosulfate/magnesium oxide/anhydrous citric acid)
			Clenpiq (sodium picosulfate/magnesium oxide/anhydrous citric acid) Executive Summary
			4/19/2023Corlanor Oral Solution (ivabradine)
			Corlanor Oral Solution Executive Summary
			4/19/2023Cystadrops ophthalmic solution (cysteamine)
			Cystadrops ophthalmic solution (cysteamine) Safety Update Memorandum
			4/19/2023Descovy (emtricitabine/tenofovir alafenamide)
			Descovy (emtricitabine/tenofovir alafenamide) Safety Update Memorandum
			4/19/2023Dysport (abobotulinumtoxinA)
			Dysport (abobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Effient (prasugrel)
			Effient (prasugrel) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Epicel (cultured epidermal autografts)
			Epicel (cultured epidermal autografts) Safety Update Memorandum
			4/19/2023Fluarix Quadrivalent (Influenza Vaccine)
			Fluarix Quadrivalent (Influenza Vaccine) Safety Update Memorandum
			4/19/2023Fycompa (perampanel)
			Fycompa (perampanel) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Granix injection (tbo-filgrastim)
			Granix injection (tbo-filgrastim) Safety Update Memorandum
			4/19/2023Harvoni (ledipasvir/sofosbuvir)
			Harvoni (ledipasvir/sofosbuvir) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Jornay PM (methylphenidate)
			Jornay PM (methylphenidate) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Katerzia oral suspension (amlodipine benzoate)
			Katerzia oral suspension (amlodipine benzoate) Safety Update Memorandum
			4/19/2023Kerydin topical solution (tavaborole)
			Kerydin topical solution (tavaborole) Safety Update Memorandum
			4/19/2023Liposorber LA-15 System (none)
			Liposorber LA-15 System Executive Summary
			4/19/2023Livalo (pitavastatin)
			Livalo (pitavastatin) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Lyrica (pregabalin)
			Lyrica (pregabalin) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Minimally Invasive Deformity Correction (MID-C) System (none)
			Minimally Invasive Deformity Correction (MID-C) System Executive Summary
			4/19/2023Prepopik for oral solution (sodium picosulfate/magnesium oxide/anhydrous citric acid)
			Prepopik for oral solution (sodium picosulfate/magnesium oxide/anhydrous citric acid) Executive Summary
			4/19/2023Procysbi (cysteamine bitartrate)
			Procysbi (cysteamine bitartrate) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023PulseRider Aneurysm Neck Reconstruction Device (none)
			PulseRider Aneurysm Neck Reconstruction Device Safety Update Memorandum
			4/19/2023Qbrexza cloth (glycopyrronium)
			Qbrexza cloth (glycopyrronium) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Seysara (sarecycline)
			Seysara (sarecycline) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Sovaldi (sofosbuvir)
			Sovaldi (sofosbuvir) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023The Tether - Vertebral Body Tethering System (none)
			The Tether - Vertebral Body Tethering System Executive Summary
			4/19/2023Twyneo cream (tretinoin/benzoyl peroxide)
			Twyneo cream (tretinoin/benzoyl peroxide) Safety Update Memorandum
			4/19/2023Winlevi cream (clascoterone)
			Winlevi cream (clascoterone) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Xeomin injection (incobotulinumtoxinA)
			Xeomin injection (incobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Zovirax injection (acyclovir)
			Zovirax injection (acyclovir) Pediatric Postmarketing Pharmacovigilance Review
			4/19/2023Dysport(abobotulinumtoxinA)
			Dysport(abobotulinumtoxinA) Pediatric Postmarketing Pharmacovigilance Review
			6/19/2023Annovera (segesterone acetate/ethinyl estradiol )
			Annovera (segesterone acetate/ethinyl estradiol ) Safety Update Memorandum
			10/26/2023Aptensio XR (methylphenidate hydrochloride)
			Aptensio XR (methylphenidate hydrochloride) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
			Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Safety Update Memorandum
			10/26/2023Contegra (none)
			Contegra Pediatric Executive Summary
			10/26/2023Dificid (fidaxomicin)
			Dificid (fidaxomicin) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Enterra Gastric Electrical Stimulator (none)
			Enterra Gastric Electrical Stimulator Executive Summary
			10/26/2023Epclusa (sofosbuvir/velpatasvir)
			Epclusa (sofosbuvir/velpatasvir) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Epclusa oral pellets (sofosbuvir/velpatasvir)
			Epclusa oral pellets (sofosbuvir/velpatasvir) Safety Update Memorandum
			10/26/2023Flector Topical System (diclofenac epolamine)
			Flector Topical System Executive Summary
			10/26/2023Flourish Pediatric Esophageal Atresia Device (none)
			Flourish Pediatric Esophageal Atresia Device Executive Summary
			10/26/2023Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed)
			Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Safety Update Memorandum
			10/26/2023Jevtana (cabazitaxel)
			Jevtana (cabazitaxel) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Nucala (mepolizumab)
			Nucala (mepolizumab) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)
			ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Executive Summary
			10/26/2023Otiprio (ciprofloxacin)
			Otiprio (ciprofloxacin) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Phexxi vaginal gel (lactic acid/citric acid/potassium bitartrate)
			Phexxi vaginal gel (lactic acid/citric acid/potassium bitartrate) Executive Summary
			10/26/2023Pleximmune (none)
			Pleximmune (none) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Promacta (eltrombopag)
			Promacta (eltrombopag) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023PulseRider Aneurysm Neck Reconstruction Device (none)
			PulseRider Aneurysm Neck Reconstruction Device Executive Summary
			10/26/2023Saxenda injection (liraglutide)
			Saxenda injection (liraglutide) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Sonalleve MR-HIFU (None)
			Sonalleve MR-HIFU Executive Summary
			10/26/2023Sorilux (calcipotriene)
			Sorilux (calcipotriene) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Tivicay PD tablets for oral suspension (dolutegravir)
			Tivicay PD tablets for oral suspension (dolutegravir) Executive Summary
			10/26/2023Tivicay tablets (dolutegravir)
			Tivicay tablets (dolutegravir) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine)
			VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) Safety Update Memorandum
			10/26/2023Victoza (liraglutide)
			Victoza (liraglutide) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Vimpat (lacosamide)
			Vimpat (lacosamide) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Yondelis injection (trabectedin)
			Yondelis injection (trabectedin) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Zerviate (cetirizine)
			Zerviate (cetirizine) Pediatric Postmarketing Pharmacovigilance Review
			10/26/2023Aczone Gel (dapsone)
			Aczone Gel (dapsone) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Adhansia XR (methylphenidate hydrochloride)
			Adhansia XR (methylphenidate hydrochloride) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Aklief (trifarotene)
			Aklief (trifarotene) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Ampicillin Injection (ampicillin)
			Ampicillin Injection (ampicillin) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Amzeeq (minocycline)
			Amzeeq (minocycline) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Arazlo (tazarotene)
			Arazlo (tazarotene) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Asmanex HFA (mometasone furoate)
			Asmanex HFA (mometasone furoate) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Baqsimi nasal powder (glucagon)
			Baqsimi nasal powder (glucagon) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Ciloxan ophthalmic solution (ciprofloxacin)
			Ciloxan ophthalmic solution (ciprofloxacin) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Conjupri (levamlodipine)
			Conjupri (levamlodipine) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Doptelet tablet (avatrombopag)
			Doptelet tablet (avatrombopag) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Dulera Inhalation Aerosol (formoterol fumarate/mometasone furoate)
			Dulera Inhalation AerosolPediatric Postmarketing Pharmacovigilance Review
			12/21/2023Dutrebis (lamivudine/raltegravir)
			Dutrebis (lamivudine/raltegravir) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Enstilar Foam (calcipotriene/betamethasone dipropionate)
			Enstilar Foam (calcipotriene/betamethasone dipropionate) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Gvoke (glucagon)
			Gvoke (glucagon) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Jublia topical solution (efinaconazole)
			Jublia topical solution (efinaconazole) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Nuvessa (metronidazole)
			Nuvessa (metronidazole) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Prezcobix tablets (darunavir/cobicistat)
			Prezcobix tablets (darunavir/cobicistat)Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Primatene Mist (epinephrine)
			Primatene Mist (epinephrine) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Quzyttir (cetirizine hydrochloride)
			Quzyttir (cetirizine hydrochloride) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Sivextro tablet (tedizolid phosphate)
			Sivextro tablet (tedizolid phosphate) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Spy Agent Green (Indocyanine green)
			Spy Agent Green (Indocyanine green) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Symtuza tablets (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide)
			Symtuza tablets (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Taclonex (calcipotriene/betamethasone dipropionate)
			Taclonex (calcipotriene/betamethasone dipropionate) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Taltz injection (ixekizumab)
			Taltz injection (ixekizumab) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Truvada (emtricitabine/tenofovir disoproxil fumarate)
			Truvada (emtricitabine/tenofovir disoproxil fumarate) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Vectical ointment (calcitriol)
			Vectical ointment (calcitriol) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023VESIcare LS oral suspension (solifenacin succinate)
			VESIcare LS oral suspension (solifenacin succinate) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Welchol (colesevelam hydrochloride)
			Welchol (colesevelam hydrochloride) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Welchol Chewable Bar (colesevelam HCl)
			Welchol Chewable Bar (colesevelam HCl) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023Xtoro (finafloxacin)
			Xtoro (finafloxacin) Pediatric Postmarketing Pharmacovigilance Review
			12/21/2023



See the Best Pharmaceuticals for Children Act, Pediatric Research Equity Act and Pediatric Medical Device Safety and Improvement Act for more information.

Pediatric Advisory Recommendations (XLSX, 70KB)Additional Resources

Listing of CDRH Humanitarian Device Exemptions

                                                                                  Content current as of:
      01/10/2024Pediatric Advisory Committee

          
                        2021 Meeting Materials, Pediatric Advisory Committee
          2023 Meeting Materials, Pediatric Advisory Committee
          Past Meeting Materials, Pediatric Advisory Committee
          Charter of the Pediatric Advisory Committee to the Food and Drug Administration
          Roster of the Pediatric Advisory Committee to the Food and Drug Administration
 
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