Pediatric investigation plans: questions and answers

Detailed guidance for sponsors applying for a pediatric investigation plan (PIP)

This page provides detailed guidance for companies intending to apply for a pediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary.

Read more online
Copyright Widler & Schiemann AG 2015. All Rights Reserved. /