Information from the Office of Pediatric Therapeutics


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Office of Pediatric Therapeutics

		Ethics Subpart D--Additional Protections for Children Involved in Clinical Trials Draft Guidance: "Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research" Hearing on October 11, 2006 Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to Food and Drug Administration Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations Pediatric Ethics Subcommittee Meetings Working Group Members Pediatric Points to Consider (PDF, 142 KB) Pediatric Checklist for CDRH (PDF, 58 KB) FDA Pediatric Working Group Consensus Statements based on the the Pediatric Advisory Subcommittee's meetings on the following dates: April 24, 2001 September 11, 2000 November 15,1999 Subpart D Working Group Members Preamble & Guidance Documents Good Clinical Practice Program International Conference on Harmonisation E11 Clinical Investigation of Medicinal Products in the Pediatric Population [PDF] Pediatric Legislation The Best Pharmaceuticals for Children Act [PDF] The Pediatric Research Equity Act [PDF] Pediatric Exclusivity Report to Congress 2001 [PDF]				BPCA Labeling Changes PREA Labeling Changes Safety Reporting Pediatric Studies Review Summaries Youth e-Station FDA Kids Page FirstGov for Kids Medicines in My Home Food Safety: For Kids, Teens & Educators Milk Matters for Kids healthfinder® Kids' Page NIDA for Teens: The Science Behind Drug Abuse BAM! Body and Mind Girl Power! GirlsHealth.gov Pediatric Advisory Committee (PAC) Charter Roster PAC Meetings -- 2007 4-11-07: Adverse Event Reporting: Lescol (fluvastatin), Sandostatin (octreotide) Adverse Event Reporting Update: Ditropan (oxybutynin chloride) and Xenical (orlistat) 4-12-07: Joint Anti-Infective Drugs Advisory Committee and the Pediatric Advisory Committee on Shiga toxin-producing bacteria PAC Meetings -- 2004-2006 Meetings of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee -- 1999-2004			In the News Join Pediatric Listserve to get the latest news on pediatrics and ethics Hot Topics Children's Health FDA Warning on Codeine Use by Nursing Mothers FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents (label) ADHD Antidepressants Elidel Safety Information Protopic Safety Information Obesity Thimerosal in Vaccines Report a Problem MedWatch VAERS (vaccines) MDR (medical devices) ADR (animal drugs) PowerPoint Presentations Current pediatric topics. Pediatric Products Vaccines, Blood, Gene Therapy Drug Development Infant Formula Devices Related Websites HHS for Kids Children's Oncology Group Office of Human Research Protection American Academy of Pediatrics Glaser Pediatric Research Network European Medicines Agency Contact Us Join the FDA_PEDS_ETHICS list Get up-to-date information on FDA's activities concerning pediatrics and ethics. PDF files may be viewed with the free Adobe Acrobat Reader.

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