Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.

ABSTRACT: Despite legislation incentivizing and requiring drug companies to conduct pediatric clinical trials, there still is a 9-year delay in drug approval for pediatric labeling after the initial adult drug approval. The aim of this study was to review the experience of the US Food and Drug Administration (FDA) with combined pediatric and adult trials as a means for expediting pediatric approval and labeling. Combined pediatric and adult trials submitted to the FDA from 2012 to 2018 were reviewed. Only the publicly available labels and reviews were utilized for this analysis. Combined trials were identified for 72 products, with a total of 156 combined adult and pediatric trials. The therapeutic areas with the largest number of combined trials were in pulmonology for products reviewed under the B

SUBMITTER: Tanaudommongkon I 

PROVIDER: S-EPMC7572516 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature