by Regulatory Affairs Professional Society
As part of an upcoming public workshop, the US Food and Drug Administration plans to learn about recent developments in pediatric pharmacovigilance from participants’ perspectives.
The goal is to “expand the conversation,” with updates gathered at the public workshop—set for 14 September—on barriers to using new solutions in pharmacovigilance. This includes “specific challenges associated with pediatric data tools,” FDA wrote in the workshop announcement.
“FDA has a specific regulatory mandate to perform pediatric pharmacovigilance and to present or make available the results of such pediatric pharmacovigilance to the Pediatric Advisory Committee,” the agency noted.
The workshop coincides with recent FDA efforts on pediatric drug development as recent legislation included a set of commitments to promote this area in medical research.
Last month, FDA also finalized guidance aimed at closing the pediatric study loophole under a current statutory exemption that allows firms to skirt requirements for certain drugs and biologics with orphan designation. The agency also adopted an addendum of the International Council for Harmonization’s guideline on pediatric drug development earlier this year.
For more information on the FDA workshop, click here.