FDA Updates Guidance Addressing Distribution of Scientific and Medical Publications on Unapproved New Uses

more+
less-

On February 28, 2014, the U.S. Food and Drug Administration (FDA) released a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices.”  The draft guidance, which sets forth principles consistent with previous agency pronouncements regarding the dissemination of off-label information, updates a guidance released in January 2009 to add recommendations pertaining to the dissemination of clinical practice guidelines that include references to off-label use of a manufacturer’s product(s).  This On the Subject provides a high-level overview of the new draft guidance.

 

Topics:  FDA, Medical Devices, Off-Label Use, Pharmaceutical, Prescription Drugs

Published In: Communications & Media Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDermott Will & Emery | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »