Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Europe’s Rx Kindergarten: Pediatric Development Plans Required Before Phase II

Executive Summary

Europe's new pediatric regulation requires all new drug development programs to adhere to a Pediatric Investigation Plan approved by the European Medicines Agency

You may also be interested in...



EU Pharma Denies Skirting Rules On Pediatric Cancer Drug Development

The European pharmaceutical industry has refuted claims that manufacturers are exploiting a loophole in EU legislation to avoid running non-lucrative trials for pediatric oncology drugs.

U.S. & EU Pediatric Drug Regulators Strive For Dialogue, Not Harmonization

Though differences in timing and design of pediatric oncology trials within U.S. and Europe regulatory frameworks may make harmonization of trial requirements impossible, they should be seen as opportunities to expand understanding of drug development in the field, FDA said at an April 16 meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

U.S. & EU Pediatric Drug Regulators Strive For Dialogue, Not Harmonization

Though differences in timing and design of pediatric oncology trials within U.S. and Europe regulatory frameworks may make harmonization of trial requirements impossible, they should be seen as opportunities to expand understanding of drug development in the field, FDA said at an April 16 meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Related Content

UsernamePublicRestriction

Register

PS048219

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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

Ask your question to our analysts

Cancel