Advisory Committees
-
Briefing Information for the May 11, 2011 Meeting of the Pediatric Ethics Subcommittee, FDA Pediatric Advisory Committee
Persons with disabilities having problems accessing any of the PDF files below may call (301) 796-3634 for assistance.
-
Briefing Information
Disclaimer: Portions of these documents have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. Sec. 552).
Letter to Subcommittee from Robert M. Nelson, M.D., Ph.D., Senior Pediatric Ethicist/Lead Medical Officer Office of Pediatric Therapeutics (PDF - 39KB)- FDA Guidance Document on Exploratory IND Studies (PDF - 220KB)
Consultation on a Pediatric Protocol, March 11, 2011 (PDF - 50KB)Drug Discovery Today: Challenges for Drug Studies in Children: CYP3A Phenotyping as Example Therapeutic Drug Monitoring: A High-Throughput Assay Using Liquid Chromatography-Tandem Mass Spectrometry for Simultaneous in vivo Phenotyping of 5 Major Cytochrome p450 Enzymes in Patients Clinical Pharmacology and Therapeutics: Reduced Activities of Cytochrome P450 1A2 and Xanthine Oxidase in Children With Growth Hormone Deficiency Clinical Pharmacology and Therapeutics: Use of Microdosing to Predict Pharmacokinetics at the Therapeutic Dose: Experience With 5 Drugs Ethical Considerations in Conducting Pediatric Research (PDF - 387KB)Cancer Chemotherapy and Pharmacology: Phase 0 Clinical Trials in Oncology: A Paradigm Shift for Early Drug Development?
-
-
-
