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

UsernamePublicRestriction
UsernamePublicRestriction

Pediatric Studies Of Systemic Atopic Dermatitis Drugs Should Start Earlier, US FDA Says

Executive Summary

Sponsors generally should begin pediatric studies after obtaining initial evidence of efficacy and safety from early phase adult trials rather than waiting until initial approval in adults, agency says in a new draft guidance; move toward earlier timeline for pediatric research aligns with recommendations from a 2015 advisory committee, and patient and professional groups.

Advertisement

Related Content

From Listening To Advising: The Maturation Of US FDA's Patient-Focused Drug Development Program
'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says
Pediatric Drug Development A Priority For US FDA’s New Oncology Center Of Excellence
Pediatric Studies: FDA Pushes Earlier Dermatitis Trials; Will It Push Others Next?

Topics

Advertisement
UsernamePublicRestriction

Register

PS122883

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