Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

EMA's PIP class waiver revisions are scientifically sound but may pose legal/ethical issues for companies

This article was originally published in SRA

Executive Summary

The European Medicines Agency's revision of its list of class waivers for pediatric investigation plans (PIPs)may result in legal or ethical challenges for pharmaceutical companies in cases where pediatric trials are requested for diseases with low prevalence in children, according to a legal expert1.

Advertisement
Advertisement
UsernamePublicRestriction

Register

PS118317

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Add a personalized Question to your Analyst

Cancel