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

FDA Warning Letters 94% In Concurrence With Chief Counsel At Six Months

This article was originally published in The Gray Sheet

Executive Summary

FDA warning and "untitled" letters are in sync with the Office of the Chief Counsel's interpretations a significant majority of the time, based on a six-month review of the policy that shifted warning letter authority from the field to the legal office

You may also be interested in...



Paper Tigers Or Paper Bullets? FDA Curbs Repeat Warning Letters, Violations

Enforcement policies under way within FDA's Office of the Chief Counsel could eliminate the practice of issuing multiple compliance warning letters, according to agency officials

Paper Tigers Or Paper Bullets? FDA Curbs Repeat Warning Letters, Violations

Enforcement policies under way within FDA's Office of the Chief Counsel could eliminate the practice of issuing multiple compliance warning letters, according to agency officials

FDA/CMS Device Trade Secret Memo Added To Regulatory Reform Wish List

FDA and CMS should issue a memorandum of understanding on maintaining confidentiality and trade secrets during collaborations between the agencies in evaluating new devices, according to the HHS Secretary's Advisory Committee on Regulatory Reform

Latest News
See All
UsernamePublicRestriction

Register

MT017215

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