Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Pediatric Exclusivity Rules May Be Revisited

This article was originally published in The Pink Sheet Daily

Executive Summary

The rules governing pediatric exclusivity awards may be revisited as a result of the investigation into the handling of pediatric antidepressant safety data

You may also be interested in...



Sen. Gregg Plans Clinical Trials Legislation For This Congressional Session

The Senate Health Committee chairman’s bill would focus on “clinical trial database issues,” while legislation planned by Sens. Kennedy, Dodd and Johnson would be directed at FDA’s authority to disclose clinical trial results, a committee staffer says.

Sen. Gregg Plans Clinical Trials Legislation For This Congressional Session

The Senate Health Committee chairman’s bill would focus on “clinical trial database issues,” while legislation planned by Sens. Kennedy, Dodd and Johnson would be directed at FDA’s authority to disclose clinical trial results, a committee staffer says.

PhRMA Clinical Trial Registry Will Be Launched Oct. 1

Clinicalstudyresults.org will include results of all controlled “hypothesis testing” clinical trials completed since October 2002 for PhRMA member companies’ marketed products. Postings will include a drug’s label, a bibliography of published studies, and summaries of unpublished studies.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS060526

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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