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


Pediatric Protocol In Written Agreement Should Be Strictly Followed - FDA

Executive Summary

NDA sponsors will be expected to precisely adhere to study protocols included in pediatric written agreements, FDA's revised guidance on pediatric exclusivity states.

You may also be interested in...

Antihypertensive Pediatric Sample Request Describes "Meaningful" Data

FDA's sample written request for antihypertensive agent pediatric information specifies what types of studies will produce "meaningful" data for pediatric labeling.

Pediatric Data Not Included In Label May Be Made Public By Alternate Means

FDA may seek to disseminate data collected from pediatric studies by alternate methods if enough sponsors do not include the results in labeling, the agency's June 29 "Qualifying for Pediatric Exclusivity" guidance states.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011



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