Pediatric drug information available at the time of new drug approvals: A cross-sectional analysis.

Joel D HudginsMatthew A BachoKaren L OlsenFlorence T Bourgeois

Published in: Pharmacoepidemiology and drug safety (2017)

These results represent a comprehensive evaluation of the study of new drugs in children and demonstrate that many drugs continue to be approved without pediatric data. Our findings serve to inform approaches to strengthen adherence to PREA requirements.

Keyphrases

drug induced
young adults
electronic health record
emergency department
machine learning
skeletal muscle
glycemic control
insulin resistance
artificial intelligence