Section 409I of the Public Health Service Act, which was created by the Best Pharmaceuticals for Children Act (BPCA), requires the National Institutes of Health (NIH), in collaboration with FDA and experts in pediatric research, to develop and publish a priority list of therapeutic areas in critical need of pediatric research. The National Institute of Child Health and Human Development (NICHD) then awards contracts to different organizations who in turn will conduct clinical trials in pediatric patients in the areas identified on the priority list. Data from these trials are to be submitted to FDA, who will determine if labeling changes are appropriate. The following table lists approved labeling changes for products studied under this program.
NIH Funded Pediatric Labeling Changes for drugs studied under the 409i process
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
