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

Sub-therapeutic Dosing In Pediatric Trials To Be Reviewed By FDA's Pediatric Ethics Subcommittee

This article was originally published in The Pink Sheet Daily

Executive Summary

Panel is called in to shed light in a growing but still controversial area.

You may also be interested in...



Children's Participation In Clinical Trials To Be Subject Of FDA Guidance

But the actual publication of a draft guidance is probably some years off, an FDA official said at a meeting of the agency's Pediatric Ethics Subcommittee.

Children's Participation In Clinical Trials To Be Subject Of FDA Guidance

But the actual publication of a draft guidance is probably some years off, an FDA official said at a meeting of the agency's Pediatric Ethics Subcommittee.

Advisory Committee To Revisit Boxed Warning For Protopic, Elidel

Six years after recommending boxed warnings and medication guides for Novartis' Elidel (pimecrolimus) and Astellas' Protopic (tacrolimus), the Pediatric Advisory Committee will hear updates on their safety.

Related Content

Topics

UsernamePublicRestriction

Register

PS072219

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