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

FDA Hands Boston Scientific Warning Letter For Clinical Trial Violations

This article was originally published in The Gray Sheet

Executive Summary

A recent bioresearch monitoring 1warning letter to Boston Scientific, sent Aug. 30, is unrelated to an outstanding corporate-wide letter issued to the firm in 2006 - but the two letters, taken together, could make life harder for the company

You may also be interested in...



Boston Scientific’s Improving ICD Sales Offset Slow Stent Revenues In Q1

Boston Scientific's recent resolution of a warning letter pertaining to quality control deficiencies at one of its cardiac rhythm management device manufacturing plants should help increase sales of the implants in the coming quarters, the firm says

Boston Scientific Stung With Across-The-Board Corporate Warning Letter

FDA is targeting Boston Scientific with a rare and far-reaching enforcement measure that could prevent some of the firm's investigational products from receiving market approval in the near term

Carotid Stent, AAA Market Entry: Boston Scientific Moves On Earn-Outs

Boston Scientific intends to acquire carotid stent manufacturer EndoTex by year-end, following an anticipated FDA approval of NexStent

UsernamePublicRestriction

Register

SC143367

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