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OHRP Special Protections for Children as Research Subjects (Index). Available from http://www.hhs.gov/ohrp/children/
Protections for Children in Research: A Report to Congress in Accord with Section 1003 of P.L. 106-310, Children's Health Act of 2000. Office for Human Research Protections. May, 2001. Available from http://www.hhs.gov/ohrp/reports/ohrp502.pdf
Related: Hearing on Protections for Foster Children Enrolled in Clinical Trials (Index). The Subcommittee on Human Resources of The Committee on Ways and Means, U.S. House of Representatives. 2005-05-18. Available from http://waysandmeans.house.gov/hearings.asp?formmode=detail&hearing=409&comm=2
Serial 109-8: Protections for Foster Children Enrolled in Clinical Trials. The Subcommittee on Human Resources of The Committee on Ways and Means, U.S. House of Representatives. 109th Congress / First Session. 2005-05-18. Available from http://waysandmeans.house.gov/hearings.asp?formmode=printfriendly&id=3055
HHS Survey of State Policies on the Participation of Foster Children in Clinical Trials. Available from http://waysandmeans.house.gov/media/pdf/welfare/062405hhssurvey.pdf. (Report courtesy of Senator Wally Herger.)
Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 (407
) Review Process. 2005-05-26. Available from http://www.hhs.gov/ohrp/children/Guidance_407Process.pdf.
Precursor Preference in Surfactant Synthesis of Newborns / Washington University Medical Center. 2005-01-13. Available from http://www.hhs.gov/ohrp/children/surfactant.html
Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder: A Functional Magnetic Resonance Study / National Institute of Mental Health. 2004-08-15. Available from http://www.hhs.gov/ohrp/children/adhd.html. (Withdrawn.)
Characterization of Mucus and Mucins in Bronchoalveolar Lavage Fluids from Infants with Cystic Fibrosis / University of North Carolina - Chapel Hill. 2004-05-14. Available from http://www.hhs.gov/ohrp/children/mucus.html
HIV replication and thymopoiesis in adolescents / University of California at Los Angeles (UCLA). 2004-03-05. Available from http://www.hhs.gov/ohrp/children/hiv.html
Sleep Mechanisms in Children: Role of Metabolism / Yeshiva University, Albert Einstein College of Medicine, Montefiore Medical Center. 2004-03-05. Available from http://www.hhs.gov/ohrp/children/sleep.html
Alcohol, sleep and circadian rhythms in young humans, study 2: Effects of evening ingestion of alcohol on sleep, circadian phase, and performance as a function of parental history of alcohol abuse/dependence / Rhode Island Hospital. 2003-12-09. Available from http://www.hhs.gov/ohrp/children/circadian.html
Precursors to Diabetes in Japanese American Youth / University of Washington and Children's Hospital and Regional Medical Center. 2003-05-27. Available from http://www.hhs.gov/ohrp/children/japanese.html
A multi-center, randomized dose-response study of the safety, clinical and immune responses of Dryvax administered to children 2 to 5 years of age / Harbor UCLA Medical Center. 2003-01-24. Available from http://www.hhs.gov/ohrp/children/dryvax.html
FDA Pediatric Drug Development Page
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Meeting Transcript. 1999-04-23. Part 1 available from http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3506t1a.pdf. Part 2 available from http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3506t1b.pdf
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Slides. 1999-04-23. Available from http://www.fda.gov/ohrms/dockets/ac/99/slides/3506s1/index.htm; http://www.fda.gov/ohrms/dockets/ac/99/slides/3506s2/index.htm; http://www.fda.gov/ohrms/dockets/ac/99/slides/3506s3/index.htm; http://www.fda.gov/ohrms/dockets/ac/99/slides/3506s4/index.htm; http://www.fda.gov/ohrms/dockets/ac/99/slides/3506s5/index.htm; http://www.fda.gov/ohrms/dockets/ac/99/slides/3506s6/index.htm
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Day 1: Ethical Issues. Meeting Transcript. 1999-11-15. Available from http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3563t1.pdf
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Day 1: Ethical Issues. Slides. 1999-11-15. Available from http://www.fda.gov/ohrms/dockets/ac/99/slides/3563s1.htm
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Meeting Transcript. 2000-09-11. Available from http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3641t1.pdf
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Briefing Information. 2000-09-11. Available from http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3641b1.htm
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Slides. 2000-09-11. Available from http://www.fda.gov/ohrms/dockets/ac/00/slides/3641s1.htm
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Meeting Transcript. 2000-09-12. Available from http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3642t1.pdf
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Briefing Information. 2000-09-12. Available from http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3642b1.htm
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Meeting Transcript. 2001-04-23 and 24. Available from http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3744t1.pdf
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Meeting Information and Transcripts. 2002-06-11. Available from http://www.fda.gov/ohrms/dockets/ac/cder02.htm#Anti-Infective
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Meeting Information and Transcripts. 2003-10-22 and 23. Available from http://www.fda.gov/ohrms/dockets/ac/cder03.html#Anti-Infective
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Meeting Index (2004 and 2005) Available from http://www.fda.gov/oc/opt/ethicsmeetings.html
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Ethics Subcommittee. Meeting Index (1999-2004). Available from http://www.fda.gov/oc/opt/anti-infectivePAC.html
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Advisory Committee. Meeting Index (2005). Available from http://www.fda.gov/oc/opt/PACmeetings.html
Department of Health and Human Services, Food and Drug Adminstration Center for Drug Evaluation and Research. Pediatric Advisory Committee. Meeting Index (2006). Available from http://www.fda.gov/ohrms/dockets/ac/oc06.htm#pac
Patient Access to New Therapeutic Agents for Pediatric Cancer / Report to Congress. 2003-12. Available from http://www.fda.gov/cder/pediatric/BPCA-ReportDec2003.doc
Pediatric Research Equity Act of 2003. 2003-12-03. URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ155.108
2006D-0172, OC 200690: Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations. Pages 27264-27266 [FR Doc. E6-07058 ] Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0172-gdl0001.pdf
Last Updated: 2006-05-23
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