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 study proposals will be prioritized by time of submission, FDA guidance states.

This article was originally published in The Tan Sheet

Executive Summary

PEDIATRIC DRUG STUDY PROPOSALS WILL BE PRIORITIZED BY TIME OF SUBMISSION and the date of expiry of marketing exclusivity or patent, FDA's June 29 "Qualifying for Pediatric Exclusivity" guidance states. The agency will give top priority review to drugs that lose marketing exclusivity on or before March 31, 1999 if the sponsor submits a proposed pediatric study request by this Aug. 31. The drug must be one of about 490 included in the priority pediatric drug list issued May 20, of which 23 are OTCs ("The Tan Sheet" May 25, p. 12).
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS088628

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