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Greater than 50% of drugs lack pediatric labeling information, resulting in widespread “off‐label” use in children. To increase pediatric prescribing information, the Pediatric Research Equity Act (PREA) was passed in… Click to show full abstract
Greater than 50% of drugs lack pediatric labeling information, resulting in widespread “off‐label” use in children. To increase pediatric prescribing information, the Pediatric Research Equity Act (PREA) was passed in 2003, requiring new drug applications to include pediatric assessments. We evaluated the study of new drugs in children since PREA was implemented.
Keywords:
information;
drug information;
information available;
new drug;
drug;
pediatric drug
Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2018
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Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2018
Link to full text (if available)
Share on Social Media: Sign Up to like & get
recommendations!