Pediatric Drug Research
Studies Conducted Under Best Pharmaceuticals for Children Act
Description:... About 2/3 of drugs prescribed for children have not been studied & labeled for pediatric use, which places children at risk of being exposed to ineffective treatment or incorrect dosing. The Best Pharm. for Children Act (BPCA), encourages the mfrs. of drugs that still have marketing exclusivity to conduct pediatric drug studies (PDS), as requested by the FDA. If they do so, FDA may extend for 6 mo. the period during which no equivalent generic drugs can be marketed. This report: assessed the extent to which PDS were being conducted under BPCA for on-patent drugs; evaluated the impact of BPCA on labeling drugs for pediatric use & the process by which the labeling was changed; & illustrated the range of diseases treated by the drugs studied under BPCA.
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