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

FDA Analysis Of Antidepressant Pediatric Suicidality Data To Be Reviewed Sept. 13-14

This article was originally published in The Pink Sheet Daily

Executive Summary

Joint meeting of Psychopharmacologic and newly formed Pediatric Advisory Committees will review analysis performed by expert group assembled by Columbia University. Future research needs in pediatric suicidality will also be addressed.

You may also be interested in...



FDA Requests Suicidality Event Review For Epilepsy Drugs

FDA is requesting that 14 manufacturers of anti-epileptic drugs re-examine clinical trial data to identify potential suicide-related adverse events. The analyses will be modeled on the agency’s recent re-examination of antidepressant data. FDA’s request to epilepsy drug sponsors follows suicidality signals seen in some trials.

FDA Requests Suicidality Event Review For Epilepsy Drugs

FDA is requesting that 14 manufacturers of anti-epileptic drugs re-examine clinical trial data to identify potential suicide-related adverse events. The analyses will be modeled on the agency’s recent re-examination of antidepressant data. FDA’s request to epilepsy drug sponsors follows suicidality signals seen in some trials.

Antidepressant Suicidality Class Risk Will Be Reviewed By Advisory Committees

FDA releases analysis of pediatric suicidality data for joint meeting of Psychopharmacologic Drugs and Pediatric Advisory Committees. The analysis could result in label changes for antidepressants, FDA Talk Paper says.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS060343

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