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  5. Products and Briefing Materials: March 6-7, 2017 Meeting of the Pediatric Advisory Committee
  1. Pediatric Advisory Committee

Products and Briefing Materials: March 6-7, 2017 Meeting of the Pediatric Advisory Committee

Persons with disabilities having problems accessing the PDF files below may call 240-402-3838 for assistance.

CDER

  1. Exjade (deferasirox)
  2. Kuvan (sapropterin dihydrochloride)
  3. Nitropress (sodium nitroprusside)

Pharmacogenomics Topic

Articles

  1. Pharmacogenomic Information in FDA-Approved Drug Labels: Application to Pediatric Patients Green, D.J., Mummaneni, P., Kim, I.W., Oh, J.M., Pacanowski, M., Burckart, G.J. Pharmacogenomic Information in FDA-Approved Drug Labels: Application to Pediatric Patients.
    Clinical Pharmacology & Therapeutics. 99, (6), 622 -632 (2016) 
  2. Clinical and regulatory considerations in pharmacogenetic testing Schuck, R.N., Marek, E., Rogers, H., Pacanowski, M. Clinical and regulatory considerations in pharmacogenetic testing.
    American Journal of Health-System Pharmacology. 73, (23), 1999-2006 (2016).

Guidances

  1. US Food and Drug Administration; Guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers
  2. Guidance for Industry: Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling

CBER

  1. EPICEL (cultured epidermal autograft)(HDE)
  2. Novoeight (turcotococog alfa) Antihemophilic Factor (Recombinant)
  3. RIXUBIS Coagulation Factor IX (Recombinant)

Pediatric HDE Devices

  1. Medtronic Activa Dystonia Therapy
  2. Impella RP System
  3. Liposorber LA-15 System

 

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