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

Antidepressants and suicide

Executive Summary

FDA's analysis of independently reviewed pediatric suicidality data for antidepressants will be discussed Sept. 13-14 during a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the newly formed Pediatric Advisory Committee. The meeting is a follow-up to a Feb. 2 meeting where advisory committee members expressed concern about the high degree of variability and lack of categorization of suicide-related events (1"The Pink Sheet" Feb. 9, 2004, p. 35). FDA's handling of the pediatric data has sparked Congressional inquiries. The meeting will be held at the Holiday Inn in Bethesda, Md. beginning at 8 a.m. [To 2watch a webcast or order video/DVDs of this meeting, go to FDAAdvisoryCommittee.com.]...

You may also be interested in...



Antidepressant Warnings On Pediatric Suicide Need Immediate Strengthening

Strengthened warnings about the risk of suicide ideation and attempts among children taking antidepressant medications should be communicated to physicians and consumers as soon as possible, a joint FDA advisory committee told the agency Feb. 2

‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation

CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.

Biogen Sees Improving Momentum In Slow Leqembi Launch

Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS044450

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