Safe and effective medicines for children pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

Safe and effective medicines for children pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

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 an...

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Bibliographic Details
Corporate Author: National Research Council (U.S.)
Other Authors: Field, Marilyn J. (Marilyn Jane) (Editor), Boat, Thomas F. (Editor)
Format: Book
Language:English
Published: Washington, D.C. National Academies Press 2012
Subjects:
Clinical Trials as Topic > Congress > legislation & jurisprudence > United States
Clinical Trials as Topic > Congress > standards > United States
Adolescent > Congress > United States
Child > Congress > United States
Drug Approval > Congress > legislation & jurisprudence > United States
Drug Evaluation > Congress > legislation & jurisprudence > United States
Drug Industry > Congress > legislation & jurisprudence > United States
Infant > Congress > United States
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