FDA Issues Draft Guidance, Requests Public Comments on Communication of Off-Label Information


The U.S. Food and Drug Administration is evaluating its policies regarding the communication of off-label information for drugs, biologics and devices, with the issuance of a draft guidance and the opening of a docket for public comments. In this newsletter, the authors summarize the agency’s draft guidance and request for public comments, and identify some key implications of these documents.

On December 27, 2011, the U.S. Food and Drug Administration (FDA) published a long-awaited draft guidance entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. The draft guidance, which is open for comment until March 29, 2012, is intended to clarify the agency’s policies regarding the manner in which a manufacturer or distributor of an FDA-approved product may respond to an unsolicited request for information regarding off-label use(s).

Please see full article below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Written by:

Published In:

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 »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name.