Activity

Pediatric Studies Conducted under BPCA and PREA


Type: Consensus Study
Topics: Biomedical and Health Research, Children, Youth and Families
Board: Board on Health Sciences Policy

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Activity Description

In response to a congressional request and with funding from the Food and Drug Adminstration, the IOM will examine studies of drugs and biologic products requested under the Best Pharmaceuticals for Children Act (BPCA) or required under the Pediatric Research Equity Act (PREA). The specific issues examined will include the use of extrapolation, alternative endpoints, and neonatal assessment tools as well as ethical issues and adverse events in BPCA or PREA studies. The study will also investigate incentives and priorities for pediatric testing of biologic products.

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