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

Pediatric Waivers Contingent On Study Attempts In Sub-Populations - FDA

Executive Summary

Sponsors may have to attempt pediatric studies in small patient populations before FDA grants a pediatric waiver, FDA suggests in a list of "Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric 'Rule,' and Their Interaction" posted on its website July 27.
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

PS034649

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