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Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee (1999-2004)

2004

• June 9, 2004
  Adverse Event Reporting: Hycamtin (topotecan), Temodar (temozolomide), Effexor (venlafaxine), Monopril (fosinopril), Allegra (fexofenadine), Duragesic (fentanyl), Ciloxan (ciprofloxacin), and Vigamox (moxifloxacin).
• June 9, 2004
  Safety report update: SSRI's and the Neonatal Withdrawal Syndrome and Congenital Malformations
• February 4, 2004
  The Use of Imaging Drugs in Conjunction with Cardiac Imaging Procedures
• February 3, 2004
  Adverse Evernt Reporting: Paxil (paroxetine), Celexa (citalopram), Pravachol (pravastatin),and Navelbine (vinorelbine)
• February 2, 2004
  Committee discussion of reports on the occurrence of suicidality in clinicaltrials for various antidepressant drugs

2003

• October 30, 2003
  Tracking Cancer Risk among Children with Atopic Dermatitis who are Treated with Topical Calcineurin Inhibitors
• October 29, 2003
  Clinical Risk Management of HPA Axis Suppression in Children with Atopic Dermatitis being treated with Topical Corticosteroids
• October 29, 2003
  Adverse Event Reporting: Zyrtec (cetirizine), Bulselfex (busulfan), Cozaar (losartan), Nolvadex (tamoxifen), Accupril (quinapril), and Serzone (nefazodone)
• June 11-12, 2003
  Management of Hyperbilirubinemia In-term and Near-term Newborns
• June 11, 2003
  Adverse Event Reporting: Zoloft (sertraline) Ditropan (oxybutynin) Lipitor (atorvastatin) and Zocor (simvastatin)
• March 3, 2003
  Antiretroviral Drug Development in HIV-Infected and HIV-Exposed Neonates

2002

• June 11, 2002
  "Written request template" for GERD in pediatric patients and the Preliminary Priority List of Drugs

2001

• April 24, 2001
  Clinical Development of Products for Drooling in Neurologically Impaired Children
• April 23, 2001
  Treatment of Chronic Hepatitis C in Children

2000

• September 12, 2000
  Pregnancy Labeling, Application of Evidence Based Medicine to Achieve Progress in Pediatric Oncology
• September 11, 2000
  Placebo-Controlled Trials in Children

1999

• November 16. 1999
  Pediatric Insomnia
• November 15, 1999
  Participation of Normal Health Pediatric Subjects in Pediatric Trials
• April 23, 1999
  Familiarize the subcommittee with its role in the agency's pediatric initiative and to obtain the subcommittee's questions and comment

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FDA Office of Pediatric Therapeutics