Medtech Insight 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

UsernamePublicRestriction
UsernamePublicRestriction

Unapproved Product Trial Data: To Post Or Not To Post On ClinicalTrials.gov?

This article was originally published in The Gray Sheet

Executive Summary

Device makers say new clinical trial registration and results reporting requirements should be extended to trials of unapproved products only if the trials were stopped for safety reasons

You may also be interested in...



Avandia Aftershocks: Will FDA Drug Safety Review Structures Crumble?

Rep. Rosa DeLauro's, D-Conn., hearing on the safety of GlaxoSmithKline's diabetes drug Avandia has ratcheted up the pressure on FDA to make broad reforms of its review structure, but the congresswoman has been careful not to urge a particular course of action for the agency

Adverse Event Reports: Posting On ClinicalTrials.gov Begins Soon

Device and drug firms must begin posting serious and frequent adverse event data from certain clinical trials on the National Institutes of Health's ClinicalTrials.gov database by September, NIH confirmed April 20

ClinicalTrials.gov Requirements Continue To Baffle Firms And Feds Alike

Device companies are not the only ones tripped up by the new ClinicalTrials.gov trial registration requirements, as FDA, NIH and others struggle to define what is and is not subject to the law

Topics

UsernamePublicRestriction

Register

MT027612

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