FDA Releases Updated Draft Guidance Addressing Initial Pediatric Studies

Sponsors that fail to address all pediatric age groups or indications in their initial pediatric study plans would have 30 days to address any deficiencies and submit a new plan, the FDA says.

Once a new iPSP is submitted to the FDA, the agency would have 210 days to consider the plan, according to updated draft guidance posted last week.  The document provides details on the content and process of an iPSP, which helps sponsors identify and plan pediatric studies during the early stages of drug development.

The new guidance includes a section detailing the content of requests for amendments to an initially agreed iPSP. Requests should include specifications of the changes with a justification, a copy of the agreed iPSP with the requested changes in red and a clean copy of the amended iPSP.