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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/16/15-9/16/15

Meeting Details:

On Wednesday, September 16, 2015, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act (FDASIA), for DUREZOL (difluprednate ophthalmic emulsion) 0.05%, Phenylephrine Hydrochloride Ophthalmic Solution, ZYLET (loteprednol etabonate and tobramycin ophthalmic suspension), BETHKIS (tobramycin Inhalation Solution), INTELENCE (etravirine), PREZISTA (darunavir), VIRAMUNE XR (nevirapine), EPIDUO (adapalene and benzoyl peroxide), EXJADE (deferasirox), DOTAREM (gadoterate meglumine), FYCOMPA (perampanel), RECOTHROM (thrombin, topical [recombinant]), PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). As mandated by the Food and Drug Administration Amendments Act, Title III, Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110– 85), the committee will discuss the safety of and the ongoing propriety of the humanitarian device exemption for the PLEXIMMUNE, ELANA SURGICAL KIT (HUD), Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), ENTERRA™ Therapy System, and CONTEGRA Pulmonary Valved Conduit.

 

       
Location: Double Tree by Hilton 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-6:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 3/24/15-3/24/15

Meeting Details:

On March 24, 2015, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). The PAC will meet to discuss the following products: CYMBALTA (duloxetine hydrochloride), QUILLIVANT XR (methylphenidate hydrochloride), LUNESTA (eszopiclone), RISPERDAL (risperidone), OXTELLAR XR (oxcarbazepine), REVATIO (sildenafil), ADVAIR HFA (fluticasone propionate/salmeterol), DYMISTA (azelastine hydrochloride/fluticasone proprionate), QNASL (beclomethasone dipropionate), VENOFER (iron sucrose), INVIRASE (saquinavir), ALTABAX Ointment (retapamulin), FluMist QUADRIVALENT (influenza vaccine live, intranasal), FLUARIX QUADRIVALENT (influenza virus vaccine), Medtronic ACTIVA DYSTONIA THERAPY, and LIPOSORBER LA-15 System. In addition, there will be a short presentation of the ethical issues discussed by the Pediatric Ethics Subcommittee of the PAC on March 23, 2015.

 

       
Location: Hilton Silver Spring Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee of the Pediatric AdComm

Meeting Date: 3/23/15-3/23/15

Meeting Details:

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart D. A brief summary of the subcommittee's discussion will then be presented to the FDA Pediatric Advisory Committee on Tuesday, March 24, 2015.

 

       
Location: Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/23/14-9/23/14

Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/21/14-4/21/14

Meeting Details:

On April 21, 2014, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107–109) and the Pediatric Research Equity Act (Pub. L. 108–155). The PAC will meet to discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor (recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), and VIREAD (tenofovir disoproxil fumarate).

 

       
Location: Bethesda Marriott 5151 Pooks Hill Road Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/19/13-9/20/13

Meeting Details:

On September 19, 2013, and September 20, 2013, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107-109) and the for Pediatric Research Equity Act (Public Law 108-155). On September 19, 2013, the PAC will meet to discuss Cervarix (human papillomavirus Bivalent (Types 16 and 18) vaccine); Gammagard Liquid (Immune Globulin Infusion (human)); Hemacord (hematopoietic progenitor cells, cord blood); Copegus and Pegasys (rivabirin and peginterferon alfa-2a); Chantix (varenicline tartrate); Isentress (raltegravir potassium); Intuniv (guanfacine), Topamax (topiramate); Faslodex (fulvestrant); Ixempra Kit (ixabepilone); and Plavix (clopidogrel bisulfate). An update on the drug program for KidNet will be provided. On September 20, 2013, the PAC will meet to discuss the Berlin Heart EXCOR Pediatric Ventricular Assist Device; Melody Transcatheter Pulmonary Heart Valve (TPV); and Elana Surgical Kit (HUD). On September 20, 2013, the committee will also receive and discuss a report on the September 9 and10, 2013, meeting of the Pediatric Ethics Subcommittee of the PAC concerning their discussion of the ethical issues involved in the development of pediatric medical countermeasures.

 

       
Location: Doubletree Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee

Meeting Date: 9/9/13-9/10/13

Meeting Details:

On September 9 and 10, 2013, the Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss ethical issues in pediatric product development, including medical counter measures, focusing on the concepts of minimal risk, disorder or condition, and exposure of pediatric subjects to risks under 21 CFR 50.54.

 

       
Location: Doubletree Hilton Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNeonatal Subcommittee of the Pediatric Advisory Committee

Meeting Date: 3/15/13-3/15/13

Meeting Details:

The Food and Drug Administration Safety and Innovation Act identified the need to expand current pediatric science to include the neonatal population. On March 15, 2013, FDA’s Neonatal Subcommittee of the Pediatric Advisory Committee will convene a non-voting session to establish an operational framework for the subcommittee as well as discuss and comment on nonspecific matters pertaining to neonatology. The subcommittee will also comment on ways to approach the challenges and identify different programmatic strategies for advancing the knowledge necessary to developing neonatal regulatory science.

 

       
Location: Sheraton Silver Spring Hotel Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 3/14/13-3/14/13

Meeting Details:

On Thursday, March 14, 2013, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107–109) and the for Pediatric Research Equity Act (Public Law 108–155) for: ACTEMRA (tocilizumab), ALIMTA (Pemetrexed disodium), CREON (pancrelipase), GADAVIST (gadobutrol), HIZENTRA [Immune Globulin Subcutaneous (Human), 20% Liquid], INOMAX (nitric oxide), INVEGA (paliperidone), KEDBUMIN (albumin human), KYTRIL Injection (granisetron hydrochloride), LAMICTAL XR (lamotrigine), MENACTRA [Meningococcal (Groups A, C, Y and W–135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine], MOXEZA (moxifloxacin ophthalmic solution 0.5%), NATROBA (spinosad), NEXIUM (esomeprazole magnesium), NEXIUM IV (esomeprazole sodium), UROXATRAL (alfuzosin hydrochloride), and ZENPEP (pancrelipase). Also, there will be an Informational Update on Codeine.

 

       
Location: Sheraton Silver Spring Hotel Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 9/11/12-9/11/12

Meeting Details:

On September 11, 2012, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107-109) and the Pediatric Research Equity Act (Public Law 108-155), for Kapvay (clonidine hydrochloride), Vyvanse (lisdexamfetamine dimesylate), Ofirmev (acetaminophen), ella (ulipristal acetate), Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol ethinyl estradiol and ferrous fumarate), Aridol (mannitol inhalation powder), Augmentin XR (amoxicillin/clavulanate potassium), Afinitor (everolimus), Moxeza (moxifloxacin hydrochloride), and Lastacaft (alcaftadine).

 

       
Location: DoubleTree by Hilton Hotel, Silver Spring Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 5/7/12-5/8/12

Meeting Details:

Agenda: On May 7, 2012, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Differin Lotion (adapalene), Dulera Inhalation Aerosol (mometasone furoate and formotorol fumarate), MultiHance Injection (gadobenate dimeglumine), Nasonex (mometasone furoate monohydrate), Natazia (estradiol valerate and estradiol valerate/dienogest), Omnaris Nasal Spray (ciclesonide), Protonix (pantoprazole), Tamiflu (oseltamivir phosphate), Taxotere (docetaxel) and Viread (tenofovir disoproxil fumarate). The committee will also receive an Informational Update on FDA’s KidNet pilot study. On May 8, 2012, the the Pediatric Advisory Committee will meet regarding the pediatricfocused safety reviews, as mandated by the Pediatric Research Equity Act, for Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, Isopto Carpine (pilocarpine hydrochloride), Menveo Meningococcal (Group A,C,Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Zylet (loteprednol etabonate and tobramycin) and Zymaxid (gatifloxacin).

 

       
Location: Hilton Rockville Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsEthical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures

Meeting Date: 2/15/12-2/16/12

Meeting Details:

The workshop will include plenaries and breakout sessions on the ethical and regulatory challenges in the development of medical countermeasures for the pediatric population. Topics of the breakout sessions will include: (1) Institutional Review Board preparedness to review study protocols relevant to pediatric medical countermeasures; (2) potential scientific and ethical justifications for conducting pre-event pediatric medical countermeasures research; (3) leveraging new technologies to develop pediatric medical countermeasures; and (4) risk communication related to pediatric treatment and research during public health emergencies. The workshop also will include discussion of a number of case studies to facilitate discussion of the challenges of pediatric medical countermeasure development and deployment.

 

       
Location: Rockville Hilton Hotel Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 1/30/12-1/31/12

Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel—releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).

 

       
Location: Hilton Gaithersburg Hotel Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the Oncologic

Meeting Date: 11/1/11-11/2/11

Meeting Details:

On November 1, 2011, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA, are in late stage development for an adult oncology indication, or in late stage development in pediatric patients with cancer. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Sodium thiosulfate injection, application submitted by Adherex Technologies, Inc.; (2) vismodegib (GDC-0449), application submitted by Genentech, Inc.; (3) pazopanib, application submitted by Glaxo Wellcome Manufacturing Pte Ltd., Singapore doing business as GlaxoSmithKline; and (4) Medi-573 (fully human antibody to IGF-I and IGF-II), application submitted by MedImmune, LLC. On November 2, 2011, the subcommittee will consider and discuss regulatory, academic, and industry perspectives regarding the development of anticoagulant products (products to suppress clotting of blood) in children. Issues for discussion will include identification of strategies to encourage and facilitate studies of anticoagulants in children that will result in informative pediatric labeling, appropriate endpoints for studies of anticoagulants in pediatric patients, and the role of pharmacokinetic/pharmacodynamic studies to support a pediatric indication for anticoagulants.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-3:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 9/22/11-9/23/11

Meeting Details:

On Thursday, September 22, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155), for Fluarix (influenza virus vaccine), Afluria (influenza virus vaccine), and Abilify (aripiprazole). There will also be an update on a study jointly funded by the Agency for Healthcare Research and Quality (AHRQ) and FDA on antipsychotic use and metabolic effects in children.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 5/16/11-5/16/11

Meeting Details:

On May 16, 2011, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107-109) and the Pediatric Research Equity Act (Public Law 110-85) for Bepreve (bepotastine besliate), Besivance (besifloxacin hydrochloride), Cetraxal (ciprofloxacin hydrochloride), Patanase Spray (olopatadine hydrochloride), Astepro Spray (azelastine hydrocholoride), Crestor (rosuvastatin calcium), Welchol (colesevelam hydrochloride), Intuniv (guanfacine), Lexapro (escitalopram oxalate), Actonel (risedronate), Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)], and Valcyte (valganciclovir). The committee will also receive further followup on Topical Calcineurin Inhibitors: Elidel (pimecrolimus) and Protopic (tacrolimus).

 

       
Location: Hilton Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee

Meeting Date: 5/11/11-5/11/11

Meeting Details:

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the general topic of the ethics of administering subtherapeutic doses of investigational products to children for the purpose of determining, for example, drug metabolism, disposition, and targeting (e.g., exploratory investigational new drug (IND) studies). In this context, the subcommittee will also discuss the referral of such protocols by an Institutional Review Board for review by a Federal panel under 21 CFR 50.54.

 

       
Location: Marriott Rockville MD Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 12/6/10-12/7/10

Meeting Details:

The Pediatric Advisory Committee (PAC) will meet to discuss donor and banked human milk. FDA is convening the meeting to obtain and discuss information and data that will provide the Agency with a better understanding of current practices, and potential benefits and risks associated with the donation and banking of human milk. Also, committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Prevista (darunavir ethanolate), PegIntron (peginterferon alfa-2b), Xyzal (levocetirizine dihydrochloride) tablet and solution, Flovent HFA (fluticasone propionate), Acanya Gel (clindamycin/benzoyl peroxide combination), Epiduo Gel (adapalene and benzoyl peroxide), Ulesfia Lotion 5% (benzyl alcohol), Axert (almotriptan), Gardasil (human papillomavirus quadrivalent types 6, 11, 16, 18, vaccine recombinant), Lamictal and Lamictal XR (lamotrigine), and Neulasta (pegfilgrastim). The committee will also receive a followup on Depakote ER (divalproex sodium). Committee members who participated in the Cardiovascular and Renal Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee meetings held on July 29, 2010, and November 5, 2010, respectively, will provide a brief summary of the meetings.

 

       
Location: Bethesda Marriott Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the Oncologic Drugs

Meeting Date: 11/30/10-11/30/10

Meeting Details:

On November 30, 2010, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA or, are in late stage development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The four products under consideration are: (1) Crizotinib, manufactured by Pfizer, Inc.; (2) pralatrexate, manufactured by Allos Therapeutics, Inc.; (3) denosumab, manufactured by Amgen, Inc.; and (4) eribulin, manufactured by Eisai Inc.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 6/21/10-6/21/10

Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Kogenate FS (antihemophilic factor (recombinant)), Casodex (bicalutamide), Apidra (insulin glulisine [rDNA]), NovoLog (insulin aspart [rDNA]), Arimidex (anastrozole), Desmopressin Acetate, Prevacid (lansoprazole), Nexium (esomeprazole magnesium), Aciphex (rabeprazole sodium), Prilosec (omeprazole), OraVerse (phentolamine mesylate), Zemuron (rocuronium bromide). The committee will also receive a follow- up presentation on Suprane (desflurane) and an overview on the Pediatric Device Consortia Grants Program.

 

       
Location: Bethesda Marriott Hotel, Congressional Ballroom, Pooks Hill, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 3/22/10-3/22/10

Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for: Anthelios 40, Cardiolite (technetium Tc-99), Nasacort AQ (triamcinolone), Viramune (nevirapine), Valtrex (valacyclovir), Zmax (azithromycin), Rotarix (rotavirus vaccine, live, oral), Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine), Pentacel [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine], and Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed vaccine). The committee will also receive an update on Topical Calcineurin Inhibitors: Elidel (pimecrolimus) and Protopic (tacrolimus). Also, the committee will receive a brief followup on the FDA Early Communication about reports of liver-related adverse events in patients taking orlistat (marketed as Alli and Xenical).

 

       
Location: Bethesda Marriott Hotel 5151 Pooks Hill Rd. Bethesda, MD., 20814 Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 12/8/09-12/8/09

Meeting Details:

On December 8, 2009, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Abilify (aripiprazole), Argatroban (argatroban), Orencia (abatacept), Humira (adalimumab), Cancidas (caspofungin acetate), Evicel--fibrin sealant (human), Artiss--fibrin sealant (human), Voluven--6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, Reyataz (atazanavir sulfate), Kaletra (lopinavir/ritonavir), Aptivus tipranavir), Zetia (ezetimibe), Vytorin (ezetimibe/simvastatin), Ventolin HFA (albuterol sulfate). An update to address some of the committee's questions from the Pediatric Advisory Committee meeting of November 18, 2008, on atypical antipsychotic drugs will be provided. In addition to Abilify (aripiprazole), Risperidal (risperidone), Zyprexa (olanzapine), Geodon (ziprasidone), and Seroquel (quetiapine) will be included. Two products (Zemuron (rocuronium bromide) and Cardiolite (technetium Tc99m estamibi) previously planned for presentation at this meeting are rescheduled for a later date.

 

       
Location: Hilton, Washington Rockville, MD 20852. Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 6/23/09-6/23/09

Meeting Details:

On June 23, 2009, the Pediatric Advisory Committee will review and discuss reports by the Agency, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Alvesco (ciclesonide), Androgel (testosterone), Asmanex (mometasone furoate), Combigan (brimonidine/timolol), Depakote (divalproex sodium), Derma-Smoothe F/S (fluocinolone acetate), Diovan (valsartan), Hepsera (adefovir dipivoxil), Inspra (eplerenone), Moxatag (amoxicillin), Omnaris (ciclesonide), and Zometa (zoledronic acid).

 

       
Location: Hilton Rockville MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric and Oncologic Drugs AdComm

Meeting Date: 4/27/09-4/27/09

Meeting Details:

On Monday, April 27, 2009, the Pediatric Advisory Committee and the Oncologic Drugs Advisory Committee will meet to discuss the scientific and ethical issues involved in obtaining and using brain biopsy specimens to evaluate gene expression patterns in children with diffuse pontine gliomas.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 11/18/08-11/18/08

Meeting Details:

On November 18, 2008, the Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports for BETOPTIC S (betaxolol), ALDARA (imiquimod), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), SANDOSTATIN (octreotide), ZYPREXA (olanzapine), RISPERDAL (risperidone), LAMISIL (terbinafine), TIMOLOL GFS (timolol), and AMBIEN (zolpidem). The committee will be provided a written followup report on ZYVOX (linezolid), as requested by the committee at the November 16, 2006, Pediatric Advisory Committee meeting. The committee will also be updated on other activities, including the June 9 and 10, 2008, Pediatric Ethics Subcommittee meeting.

 

       
Location: Holiday Inn Gaithersburg Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee of the Pediatric AdComm

Meeting Date: 6/9/08-6/10/08

Meeting Details:

On June 9, 2008, the Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the application of 21 CFR 50.52 (Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects) to FDA regulated research. The discussion will be illustrated with hypothetical case examples of research involving HIV vaccines in adolescents and controlled trials of inhaled corticosteroids in children with asthma. On June 10, 2008, the Subcommittee will meet to discuss the application of 21 CFR 50.52 to FDA regulated research illustrated with a hypothetical case example of research using stem cells for treating periventricular white matter injury in children.

 

       
Location: Holiday Inn Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 3/25/08-3/25/08

Meeting Details:

On March 25, 2008, the Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act, on adverse event reports for TOPROL XL (metoprolol), BREVIBLOC (esmolol HCl), LOTENSIN (benazepril), COREG (carvedilol), COLAZAL (balsalazide), ELOXATIN (oxaliplatin), CELEBREX (celecoxib), and SUPRANE (desflurane).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 11/27/07-11/29/07

Meeting Details:

On November 27, 2007, in response to the Pediatric Advisory Committee’s 2005 request for specific updates after 2 additional years of influenza seasons, the committee will receive information on adverse event reports, focusing on neuropsychiatric and behavioral events, for Tamiflu (OSELTAMIVIR). On November 28, 2007, the Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports for Serevent (SALMETEROL), Provigil (MODAFINIL), Azopt (BRINZOLAMIDE), Bextaxon (LEVOBETAXOLOL), Emtrivia (EMTRICITABINE), and Gleevec (IMATINAB MESYLATE). The Pediatric Advisory Committee will also hear about and discuss the Pediatric Initiatives between FDA and the European Medicines Agency. On November 29, 2007 the Pediatric Advisory Committee will hear and discuss issues related to FDA’s draft guidance for Industry entitled ‘‘Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling,’’ that published in the Federal Register of Tuesday, February 8, 2005 (70 FR 6697). As part of the review and consideration of public comments received by FDA in response to this draft guidance, the Pediatric Advisory Committee will hear and discuss information on: Labeling of drugs for use by lactating women; breastfeeding physiology, benefits, and current research; the physiology and pharmacology of drug transfer into breast milk; and ethical issues related to studying breastfeeding mother/infant pairs.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 6/27/07-6/27/07

Meeting Details:

The subcommittee will do the following: (1) Discuss review of oncology products granted pediatric exclusivity under the Best Pharmaceuticals for Children Act (BPCA); and (2) discuss 13-cis retinoic acid: summary of clinical experience, including access through iPledge, and additional clinical studies for the treatment of patients with neuroblastoma to be conducted under the BPCA.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 4/11/07-4/11/07

Meeting Details:

The Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act, on adverse event reports for iluvastatin (LESCOL) and octreotide (SANDOSTATIN). The committee will also receive updates to adverse event reports for orlistat (XENICAL) and oxybutynin (DITROPAN) which were requested by the Pediatric Advisory Committee when the reports were first presented.

 

       
Location: TBA Related News Links: Not Available
Time: 4:00PM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee of the Oncologic AdComm

Meeting Date: 12/6/06-12/6/06

Meeting Details:

The subcommittee will consider endpoints for trials intended to support the approval of new drugs to treat pediatric brain tumors.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 11/16/06-11/16/06

Meeting Details:

The Pediatric Advisory Committee will hear and discuss a report by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act, on adverse event reports for ertapenem (INVANZ), gemcitabine (GEMZAR), glimepiride (AMARYL), insulin aspart recombinant (NOVOLOG), linezolid (ZYVOX), meloxicam (MOBIC), ondansetron (ZOFRAN), oxcarbazepine (TRILEPTAL), ritonavir (NORVIR), rosiglitazone (AVANDIA), sirolimus (RAPAMUNE). The committee will also receive updates to adverse event reports for atorvastatin (LIPITOR), citalopram (CELEXA), oseltamivir (TAMIFLU), oxybutynin (DITROPAN), and simvastatin (ZOCOR), which were requested by the Pediatric Advisory Committee or its predecessor, the Pediatric Subcommittee of the Anti- Infective Drugs Advisory Committee, when the reports were first presented.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 3/22/06-3/22/06

Meeting Details:

The Pediatric Advisory Committee will hear and discuss a report by the agency, as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports possibly related to clofarabine (CLOLAR), irbesartan (AVAPRO), sibutramine (MERIDIA), and the mixed salts amphetamine product (ADDERALL). In continuation of a prior committee discussion of adverse events for the class of methylphenidate products used to treat attention deficit hyperactivity disorder (ADHD), the committee will hear and discuss neuropsychiatric adverse events possibly related to other approved ADHD medications. The presentations will focus on neuropsychiatric adverse event reports and clinical trial data from approved ADHD medications. The committee will also receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD medications.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 7:30AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Oncology Subcommittee

Meeting Date: 3/14/06-3/14/06

Meeting Details:

The subcommittee will discuss the following: (1) Clinical studies of methotrexate and daunomycin to be conducted under the Best Pharmaceuticals for Children Act; (2) phase 4 requirements for Deferasirox, Novartis Pharmaceuticals, as mandated under accelerated approval; and (3) the Center for Drug Evaluation and Research's process for handling drug shortages.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 11/18/05-11/18/05

Meeting Details:

The committee will discuss a report by the agency on Adverse Event Reporting, as mandated in Section 17 of the Best Pharmaceuticals for Children Act, for AGRYLIN (anagrelide), PARAPLATIN (carboplatin), DIFLUCAN (fluconazole), CAMPTOSAR (irinotecan), TAMIFLU (oseltamivir), VIOXX (rofecoxib), FERRLECIT (sodium ferric gluconate complex), and IMITREX (sumatriptan).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 11/16/05-11/17/05

Meeting Details:

On Wednesday, November 16, 2005, the committee will hear and discuss the recommendation of the Pediatric Ethics Subcommittee from its meeting on November 15, 2005, regarding a referral by an Institution Review Board of a proposed clinical investigation involving children as subjects that is regulated by FDA and is conducted or supported by the Department of Health and Human Services (DHHS). The committee will also discuss pediatric obesity and clinical trial designs for the evaluation of devices intended to treat pediatric obesity. On Thursday, November 17, 2005, the committee continue its discussion of clinical trial designs for, and ethical issues related to, the evaluation of devices intended to treat pediatric obesity.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee

Meeting Date: 11/15/05-11/15/05

Meeting Details:

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss a referral by an Institutional Review Board (IRB) of a proposed clinical investigation involving children as subjects, that is regulated by FDA and may be supported by HHS. The proposed clinical investigation is entitled "Gonadotropin-releasing Hormone (GnRH) Agonist Test in Disorders of Puberty." Because the proposed clinical investigation would be regulated by FDA, and conducted or supported by HHS, both FDA and the Office for Human Research Protections, HHS, will participate in the meeting. After presentation of an overview of the IRB referral process, background information on disorders of puberty and hormonal actions of leuprolide, an overview of the protocol and the referring IRB's deliberations on the protocol, and a summary of public comments received concerning whether the protocol should proceed, the subcommittee will discuss the proposed protocol and develop a recommendation regarding whether the protocol should proceed.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 6/29/05-6/30/05

Meeting Details:

On Wednesday, June 29, 2005, the committee will hear and discuss the recommendation of the Pediatric Ethics Subcommittee from its meeting on June 28, 2005, regarding a referral by an Institution Review Board of a proposed clinical investigation involving children as subjects that is regulated by FDA and is conducted or supported by DHHS. The committee will also discuss a report by the agency on Adverse Event Reporting, as mandated in section 17 of the Best Pharmaceuticals for Children Act (BPCA), for ethinyl estradiol; norgestimate (ORTHO TRI-CYCLEN), ciprofloxacin (CIPRO), tolterodine (DETROL LA), leflunomide (ARAVE), paricalcitol (ZEMPLAR), zolmitriptan (ZOMIG), dorzolamide (TRUSOPT). On Thursday, June 30, 2005, the committee will discuss a report by the agency on Adverse Event Reporting, as mandated in section 17 of the BPCA, for methylphendidate (CONCERTA and other methtylphenidates).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:30PM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee

Meeting Date: 6/28/05-6/28/05

Meeting Details:

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss a referral by an Institutional Review Board (IRB) of a proposed clinical investigation that involves both an FDA regulated product and research involving children as subjects that may be supported by HHS. The proposed clinical investigation is entitled "Precursor Preference in Surfactant Synthesis of Newborns." Because the proposed clinical investigation would be regulated by FDA, and conducted or supported by HHS; both FDA and the Office for Human Research Protections, HHS, will participate in the meeting. After presentation of an overview of the IRB referral process, background information on surfactant synthesis, an overview of the protocol and the referring IRB's deliberations on the protocol, and a summary of public comments received concerning whether the protocol should proceed, the subcommittee will discuss the proposed protocol and develop a recommendation regarding whether the protocol should proceed. The subcommittee's recommendation will then be presented to the FDA Pediatric Advisory Committee meeting on June 29, 2005.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 2/14/05-2/15/05

Meeting Details:

On Monday, February 14, 2005, the committee will discuss an agency report on Adverse Event Reporting, as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA), for LOTENSIN (benazepril), BREVIBLOC (esmolol), MALARONE (atovaquone/proguanil), VIRACEPT (nelfinavir), XENICAL (orlistat), and GLUCOVANCE (glyburide/metformin). The committee will also be asked to advise the agency on how to improve the process and content of the adverse event reviews and reporting as mandated by BPCA. On Tuesday, February 15, 2005, the committee will discuss risk evaluation, labeling, risk communication, and dissemination of information on potential cancer risk among pediatric patients treated for atopic dermatitis with topical dermatological immunosuppressants.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 2:00PM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 9/15/04-9/15/04

Meeting Details:

The committee will discuss: (1) The recommendation of the Pediatric Ethics Subcommittee from its meeting on September 10, 2004, regarding a referral by an Institution Review Board under 21 CFR 50.54 and 45 CFR 46.407 of a proposed clinical investigation that involves both an FDA regulated product and research involving children as subjects that is conducted or supported by the DHHS, and (2) a report by the agency on Adverse Event Reporting, as mandated in section 17 of the Best Pharmaceuticals for Children Act, for PULMICORT/RHINOCORT (budesonide), CLARINEX (desloratadine), CUTIVATE/FLONASE/FLOVENT (fluticasone), OCULFOX (ofloxacin), FLUDARA (fludarabine), and FOSAMAX (alendronate).

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 8:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Ethics Subcommittee of the Pediatric Advisory Committee

Meeting Date: 9/10/04-9/10/04

Meeting Details:

On Friday, September 10, 2004, the Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss a referral by an Institution Review Board (IRB) of a proposed clinical investigation that involves both an FDA-regulated product and research involving children as subjects that is conducted or supported by HHS. The proposed clinical investigation is entitled ‘‘Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder (ADHD): A Functional Magnetic Resonance Study.’’ Because the proposed clinical investigation would be regulated by FDA, and conducted or supported by HHS, both FDA and the Office for Human Research Protections, HHS, will participate in the meeting. After presentation of an overview of the IRB referral process, background information on ADHD, an overview of the protocol and the referring IRB’s deliberations on the protocol, and a summary of public comments received concerning whether the protocol should proceed, the subcommittee will discuss the proposed protocol and develop a recommendation regarding whether the protocol should proceed. The subcommittee’s recommendation will then be presented to the FDA Pediatric Advisory Committee on September 15, 2004; the announcement of the September 15, 2004, meeting can be found elsewhere in this issue of the Federal Register.

 

       
Location: Double Tree Hotel Regency Room 1750 Rockville Pike Rockville, MD Related News Links: Not Available
Time: 8:30AM-3:30PM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 2/9/16-2/9/16

Broadcasting Live NOW

Meeting Details:

The committee will discuss biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 2/18/16-2/18/16

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Meeting Details:

The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology. Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 2/19/16-2/19/16

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Meeting Details:

The Committee will discuss the premarket application for the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5. DDD is confirmed radiographically with one or more of the following factors: (1) Patients must have greater than 2 millimeters of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. Amended: The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 2/25/16-2/26/16

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Meeting Details:

On February 25, 2016, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for ``TOPAS Treatment for Fecal Incontinence,' by ASTORA Women's Health, LLC. The ``TOPAS Treatment for Fecal Incontinence' device is a sling device (mesh) to be implanted around the puborectalis muscle (a muscle that contributes towards the maintenance of fecal continence). The proposed Indication for Use (IFU) for the ``TOPAS Treatment for Fecal Incontinence' device, as stated in the PMA, is as follows: The ``TOPAS Treatment for Fecal Incontinence' is intended to treat women with fecal incontinence (also referred to as accidental bowel leakage) who have failed more conservative therapies. On February 26, 2016, during session I, the committee will discuss and make recommendations regarding the reclassification of urogynecologic surgical mesh instrumentation from class I to class II. The applicable product codes are those related to urogynecologic surgical mesh as follows: OTN and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAG and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, female, multi-incision;' PAH and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, single-incision mini-sling;' OTO and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' PAJ and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed;' OTP and the associated device classification name, ``mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed' and PAI and the associated device classification name, ``mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed.' Some examples of the means by which these devices perform these functions and their respective IFU/Intended Use (IU) statements are: Urogynecologic surgical mesh instrumentation is used: [cir] IFU/IU: To aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment of female stress urinary incontinence. Examples of such surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. The committee, during session II, will discuss and make recommendations regarding the classification of the product code ``LKX' and the associated device classification name, ``Device, Thermal, Hemorrhoids.' The product code LKX represents a category of devices intended to apply controlled cooling and conductive heating to hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an aluminum probe that contains a temperature sensitive element to regulate temperature within 2 degrees (between 37 and 46 degrees centigrade). [cir] IFU/IU: The apparatus is intended to apply controlled, conductive heating to hemorrhoids. Uses a heat applicator inserted into the rectum, applicator contains a battery operated heater, and a sensor which provides temperature control/feedback. [cir] IFU/IU: Intended to provide temporary relief of the symptoms of hemorrhoids through the application of mild heating. Uses speculum-like plastic container containing liquid to cool hemorrhoidal veins. [cir] IFU/IU: Treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. The committee, during session III, will discuss and make recommendations regarding the classification of the product code ``LRL' and the associated device classification name, ``Cushion, Hemorrhoid.' The product code LRL represents a category of devices intended to temporarily relieve pain and pressure caused by hemorrhoids. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Uses an injection molded polypropylene copolymer plastic seat attached to a toilet seat (the product is adjustable and is available in round and elongated versions). [cir] IFU/IU: For the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only. Uses a cushion with an inflatable vinyl exterior and a foam center. An air chamber, when filled, prevents the cushion from compressing the foam. A urethane foam center adds comfort. [cir] IFU/IU: Intended for the home convalescent patient with perineal discomfort. Uses a cushion that contains two internal molded structures that conform to the patient's shape. Exerts ``slight' pressure on hemorrhoid. IFU/IU not required at the time of clearance. The committee, during session IV, will discuss and make recommendations regarding the classification of the product code ``LKN' and the associated device classification name, ``Separator, automated, blood cell and plasma, therapeutic.' The product code LKN represents a category of centrifuge-type devices intended to separate blood components and perform therapeutic plasma exchange for the management of serious medical conditions in adults and children. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments [[Page 940]] became effective. Some examples of the means by which these devices perform these functions and their respective IFU/IU statements are: Utilizes a continuous flow centrifuge (max speed 3000 revolutions per minute) to separate source blood from a subject into blood components. [cir] IFU/IU: May be used to perform therapeutic plasma exchange. [cir] IFU/IU: May be used to perform Red Blood Cell Exchange procedures for the transfusion management of Sickle Cell Disease in adults and children. Uses continuous flow access to a rotating centrifuge to separate blood components. [cir] IFU/IU: May be used to harvest cellular components from the blood of certain patients where the attending physician feels the removal of such component may benefit the patient. [cir] IFU/IU: May be used to remove plasma components and/or fluid selected by the attending physicians.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/16-3/4/16

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Meeting Details:

On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season.

 

       
Location: TBD Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 3/15/16-3/16/16

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Meeting Details:

On March 15, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System sponsored by Abbott Vascular. The Absorb GT1 BVS System is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length = 24 millimeters (mm)) with a reference vessel diameter of = 2.5 mm and = 3.75 mm. On March 16, 2016, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AngelMed Guardian System sponsored by Angel Medical Systems, Inc. The AngelMed Guardian System is an implantable cardiac monitor intended to alert patients to ST segment shifts indicating coronary ischemia. The AngelMed Guardian System is intended for use in patients with prior acute coronary syndrome events, and at risk for recurrent events, to ST segment changes indicating cardiac ischemia.

 

       
Location: Holiday Inn Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs Advisory Committee

Meeting Date: 2/3/16-2/3/16

Meeting Details:

During the morning session, the committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. During the afternoon session, the committee will discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPOSTPONED: Peripheral and Central Nervous System Drugs AdComm

Meeting Date: 1/22/16-1/22/16

Meeting Details:

The postponement is due to inclement weather forecasted for the Washington, DC area. The committee will discuss new drug application 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAllergenic Products AdComm

Meeting Date: 1/21/16-1/21/16

Meeting Details:

The committees will discuss safety and effectiveness data, including challenge study endpoints, for licensure of food allergy immunotherapy products, and the clinical development of aeroallergen immunotherapy products for the prevention of respiratory allergic disease.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPsychopharmacologic Drugs AdComm - PROBUPHINE

Meeting Date: 1/12/16-1/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc., on behalf of Titan Pharmaceuticals for the proposed indication of maintenance treatment of opioid dependence.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis AdComm

Meeting Date: 2/9/16-2/9/16

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Meeting Description:

The committee will discuss biologics license application (BLA) 125544, for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.


 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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