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


FDA Spells Out Details Of Premarket Clinical Trial Inspections

This article was originally published in The Gray Sheet

Executive Summary

A final guidance document released by FDA Jan. 8 gives the timetable that device makers can expect when PMA applications and supplements are reviewed by the device center's bioresearch monitoring division

You may also be interested in...

“For Cause” Inspections Find Galloping Clinical Trial Violation Rate

The violation rate for clinical trial sponsors shot up in fiscal year 2007, hitting a 10-year high, with FDA finding many of the problems during inspections triggered by complaints, according to CDRH

FDA Clinical Trial Inspection Process Detailed In Draft Guidance

A new draft 1guidance explains CDRH's process for ensuring the integrity of data included in device premarket approval submissions

Belgium Aims To Drive Biologic Competition Through Tendering

New tendering rules in Belgium aim to improve competition between biosimilars and originators, for example by setting contract durations for tendering contracts and limiting the criteria for such contracts.

Latest Headlines
See All



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