Safe and Effective Medicines for Children Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (2012) / Chapter Skim
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Appendix A: Study Activities, Methods, and Public Meetings
Appendix A: Study Activities, Methods, and Public Meetings
Pages 261-270
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From page 261... ...
review and assess a representative sample of studies conducted since 1997 under PREA or precursor regulations, and labeling changes made as a result of such studies; 3. using a representative sample of written requests issued by the Sec retary and studies conducted under BPCA since 1997 and studies conducted since 1997 under PREA or precursor regulations, review and assess (a)
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From page 262... ...
Three of these meetings included public sessions during which the committee heard from a range of interested parties, including government officials from FDA and the National Institutes of Health and individuals from organizations representing pharmaceutical and biotechnology companies, pediatricians, researchers, and advocates. The agendas for the public sessions follow this overview of study activities and methods.
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From page 263... ...
Some products had more than one labeling change. Neither the list supplied by FDA nor an online table of labeling changes explained that the list omitted changes made before September 27, 2007, for biologics that are regulated under the Public Health Service Act.1 FDA was unable to supply a list of these omitted labeling changes.
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From page 264... ...
Moreover, the need for vaccines for various diseases and populations is closely monitored by several government agencies, including the National Vaccine Program, the Advisory Committee on Immunization Practices, and the FDA's Vaccines and Related Biological Products Advisory Committee. Appendix D includes a brief description of the extent of pediatric labeling and pediatric studies for vaccines for which FDA has posted some supporting documents.
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From page 265... ...
The committee supplemented the sample of written requests with additional requests in three areas: migraine, pediatric hypertension, and gastroesophageal reflux disease. It also reviewed requests, reviews, and other documents for many additional products or labeling changes as it investigated particular issues (e.g., neonatal studies)
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From page 266... ...
Judith Cope, M.D., M.P.H., Office of Pediatric Therapeutics Questions from the committee 1:30–2:45 OPEN SESSION II Welcome and introductions Role of the National Institute of Child Health and Human Development in BPCA Anne Zajicek, M.D., Pharm.D., Chief, Obstetric and Pediatric Pharmacology Branch, Center for Research for Mothers and Children Information and process to support priority setting Clifford Goodman, Ph.D., Vice President, The Lewin Group Cynthia Schuster, M.P.P., The Lewin Group Questions from the committee
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* INSTITUTE OF MEDICINE COMMITTEE ON PEDIATRIC STUDIES CONDUCTED UNDER BPCA AND PREA MEETING 2: February 2, 2011 Keck Building, 500 Fifth Street, NW, Washington, DC AGENDA: OPEN SESSION 11:00–Noon Thomas Boat, M.D., Committee Chair Welcome and chair's statement Lisa Mathis, M.D., Center for Drug Evaluation and Research PREA waivers and deferrals and other issues Julia Dunne, M.D., Office of Pediatric Therapeutics European Medicines Agency (EMEA)
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From page 268... ...
Chair, AACAP Pediatric Psychopharmacology Initiative Director of Psychiatric Clinical Trials Children's National Medical Center, Washington, DC Pediatric Rheumatology Collaborative Study Group Daniel J Lovell, M.D., M.P.H.
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From page 269... ...
269 APPENDIX A Director, Special Immunology Pediatric HIV Program Children's National Medical Center, Washington, DC Questions from the committee 3:00 Adjourn Written statements submitted for this meeting: Childhood Arthritis and Rheumatology Research Alliance (CARRA) Friends of CARRA
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