
(AGENPARL) – SILVER SPRING mar 28 marzo 2023 Section 409i of BPCA requires NIH and FDA to prioritize therapeutic areas in critical need of pediatric research. NICHD then facilitates clinical trials and data are submitted to FDA who determines if labeling changes are appropriate. This site lists such approved labeling changes.
Fonte/Source: http://www.fda.gov/drugs/development-resources/nih-funded-pediatric-labeling-changes-drugs-studied-under-409i-process