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.

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.

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).

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).

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.

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).

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.

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.

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).

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.

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.

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.

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.

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).

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.

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).

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.

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.

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.

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).

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.

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.

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.

Meeting Details:

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

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.

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.

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.

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).

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.

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.

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).

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.

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.

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).

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.

Meeting Details:

On June 5 and 6, 2013, the committees will discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for new drug application (NDA) 21071, AVANDIA (rosiglitazone maleate) tablets. Rosiglitazone is a thiazolidinedione, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. AVANDIA is manufactured by GlaxoSmithKline.

Meeting Details:

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and 3 • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

Meeting Details:

On June 27, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. The class III sorbent hemoperfusion system is a device intended for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances. It consists of an extracorporeal blood system and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated carbon or resins, which may be coated or immobilized to prevent fine particles from entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. Sorbent hemoperfusion systems may also include the machine or instrument used to drive and manage blood and fluid flow within the extracorporeal circuit, as well as any accompanying controllers, monitors, or sensors. On April 4, 2013 (78 FR 20268), FDA issued a proposed order which, if made final, would reclassify sorbent hemoperfusion systems labeled for the treatment of poisoning and drug overdose class II subject to premarket notification [510(k)] and special controls, while sorbent hemoperfusion systems labeled for the treatment of hepatic coma and metabolic disturbances would remain class III requiring premarket approval (PMA) applications. The committee’s discussion will involve making recommendations regarding the regulatory classifications noted above. The committee will also discuss whether the proposed special controls are adequate to reasonably ensure the safety and effectiveness of sorbent hemoperfusion devices labeled for the 3 treatment of poisoning and drug overdose. The regulatory history of sorbent hemoperfusion has been discussed as part of a previously published proposed rule (77 FR 9610). During session II on June 27, 2013, the committee will discuss and make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. The class III implanted blood access devices for hemodialysis include various flexible or rigid tubes, such as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic catheters that have a subcutaneous “cuff”' for tissue ingrowth. They are placed in a central vein to allow blood access. Chronic hemodialysis catheters serve as conduits for the removal of blood from the patient, delivery to a hemodialysis machine for filtering, and return of filtered blood to the patient. They have no moving parts, consisting, essentially, of flexible tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous catheters are totally implanted below the skin surface with no external communication. Arteriovenous shunts and vessel tips are tubing with tapered tips that are inserted into the artery and vein. The tubing is attached to the roughened or etched outer surface of the tip. The tubing is external to the skin and can be accessed with needles. They are similar to subcutaneous catheters. On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which, if made final, would make the class III implanted blood access devices class II subject to premarket notification [510(k)] and special controls. The regulatory history of implanted blood access devices has been discussed as part of the proposed rule (77 FR 36951). The committee’s discussion will involve making recommendations regarding regulatory classification to either reaffirm class III or reclassify these devices into class II and comment on 4 whether special controls are adequate to reasonably ensure the safety and effectiveness of this device.

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On July 10, 2013, the Agency plans to discuss the risk management of LOTRONEX (alosetron hydrochloride) tablets, by Prometheus Laboratories Inc., which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS-d). The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system.

Meeting Details:

On July 18, 2013, the committee will discuss new drug application (NDA) 022225, sugammadex sodium injection, submitted by Organon USA Inc., for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at 3 minutes after administration of rocuronium.

Meeting Details:

On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is indicated for reconstruction of the intervertebral disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the disc space. On July 25, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5- S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies.

Meeting Details:

On May 22, 2013, the committee will discuss new drug application (NDA) 204569, for suvorexant tablets, submitted by Merck Sharp and Dohme Corp., Worldwide Regulatory Group. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance.

Meeting Details:

On May 3, 3013, the committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. (Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.) Currently approved LGFs are licensed under biological license applications (BLAs): 103353, NEUPOGEN (filgrastim, Amgen, Inc.), 125031, NEULASTA (pegfilgrastim, Amgen, Inc.), 103362, LEUKINE, (sargramostim, Genzyme, Inc.), and 125294, TBO–FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for filgrastim, based on treatment in an animal model of radiation-induced myelosuppression. Safety and other supportive information are currently described in the labeling for LGFs.

Meeting Details:

During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma. During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.

Meeting Details:

On May 2, 2013, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juv[eacute]derm Voluma XC sponsored by Allergan, Inc. Juv[eacute]derm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juv[eacute]derm Voluma XC is indicated for deep (dermal/subcutaneous and/or submuscular/ supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement.

Meeting Details:

On April 29 and 30, 2013, the Committee will discuss general factors in risk communication about FDA-regulated products, including how to communicate effectively about FDA’s adverse event reporting systems, and messaging in the context of competing communicators.

Meeting Details:

On April 25, 2013, during session I, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre- Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Methotrexate,” Product Code LAO, as unclassified under the 510(k) premarket notification authority. Methotrexate enzyme immunoassays are for the quantitative determination of methotrexate. The measurements obtained are used in monitoring levels of methotrexate to ensure appropriate drug therapy. FDA is seeking panel input on the safety and effectiveness of methotrexate enzyme immunoassays. On April 25, 2013, during session II, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as phencyclidine (PCP) enzyme immunoassays and PCP radioimmunoassays. PCP enzyme immunoassays and PCP radioimmunoassays are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. PCP enzyme immunoassays are currently regulated under the heading of “Enzyme Immunoassay, Phencyclidine,” Product Code LCM, and “Radioimmunoassay, Phencyclidine,” Product Code LCL, as unclassified under the 510(k) premarket notification authority. FDA is seeking panel input on the safety and effectiveness of PCP enzyme immunoassays and PCP radioimmunoassays. 3 On April 25, 2013, the committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were in commercial distribution prior to May 28, 1976 when the Medical Device Amendments became effective. Isoniazid test strips are currently regulated under the heading of “Strip, Test Isoniazid,” Product Code MIG, as unclassified under the 510(k) premarket notification authority. Isoniazid test strips are a qualitative assay used for detecting isonicotinic acid and its metabolites in urine to determine compliance of isoniazid (INH) medication. FDA is seeking panel input on the safety and effectiveness of isoniazid test strips.