Safe and effective medicines for children : studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA), Institute of Medicine of the National Academies ; edited by Marilyn J. Field and Thomas F. Boat.
"The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and P...
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| Online Access: |
Full Text (via ProQuest) |
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| Corporate Authors: | , |
| Other Authors: | , |
| Format: | eBook |
| Language: | English |
| Published: |
Washington, D.C. :
National Academies Press,
2012.
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| Subjects: |
| Summary: | "The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children"--Publisher's description. |
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| Physical Description: | 1 online resource (xxiii, 408 pages) : illustrations (some color) |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 0309225507 9780309225502 6613948802 9786613948809 |
| Source of Description, Etc. Note: | Print version record. |