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FDA Draft Guidance Extends Reprint Policy To Medical Reference Texts, Clinical Practice Guidelines

This article was originally published in The Gray Sheet

Executive Summary

FDA has revised, but not loosened, its 2009 policy on the practices manufacturers should follow when giving physicians reprints of journal articles and other publications that discuss unapproved uses of legally marketed medical devices and drugs.

You may also be interested in...



Off-Label Questions, Online: FDA Explains How To Handle Them

FDA draft guidance weighs in on web communications, saying that firms must answer off-label-information questions privately, even if the questions arise in a public online forum.

FDA Issues Guidance On Off-Label Info; Waxman Seeks ‘Re-examination’

Rep. Henry Waxman is calling for the Obama administration to re-examine a final FDA guidance that gives companies a way to distribute journal articles discussing off-label uses for approved medical devices and drugs

QUOTED. 4 December. Eric Borin.

Becton Dickinson will spend $1.2bn over the next four years to improve its drug-delivery device manufacturing capabilities. See what Eric Borin, president of BD, said about it here.

Topics

Related Companies

UsernamePublicRestriction

Register

OM013133

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