Medtech Insight 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

Antidepressant Manufacturers’ Trial Information Requested By Senate Cmte.

This article was originally published in The Pink Sheet Daily

Executive Summary

Finance Chairman Grassley asks eight manufacturers for list of all pediatric antidepressant trials, including completion, publication and FDA submission information. Grassley expresses concern that the firms may not have provided FDA with all the information “at their disposal.”

You may also be interested in...



FDA Should Issue Pediatric Antidepressant Trial Summaries, Rep. Waxman Says

The congressman's letter requests the immediate release of data for drugs that gained six months of additional exclusivity under the Best Pharmaceuticals for Children Act. While seven companies have gained exclusivity extensions for antidepressants, data on only two are available, he says.

Grassley Expands FDA Drug Safety Inquiry

Senate Finance Committee Chairman Chuck Grassley (R-Iowa) has requested that the General Accounting Office review the relationship between FDA's Office of Drug Safety and Office of New Drugs

GSK's Nucala Is Significantly Overpriced, ICER Draft Report Finds

New biologic for severe asthma doesn't stack up well to standard of care on generally accepted levels of cost per quality-adjusted life year.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS060463

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