FDA seeks comments on new draft guidance clarifying good reprint practices

In a 3 March 2014 Federal Register notice, the US Food and Drug Administration (FDA) distributed a revised draft guidance document titled ‘Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices’ for comment. The draft guidance, when finalised, is intended to replace FDA’s January 2009 final guidance titled ‘Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices’. While the draft guidance is largely consistent with the 2009 guidance, restating and providing additional details that build on the existing criteria for the distribution of journal articles describing unapproved uses of drugs and medical devices, it does include new requirements for the dissemination of medical or scientific reference texts and clinical practice guidelines (CPGs), neither of which are explicitly discussed in the 2009 guidance.

The most notable difference between the draft guidance and the 2009 guidance is the introduction of a new category of publications, i.e. CPGs, that can fall within the ‘safe harbour’ for distribution of publications that discuss unapproved uses of drugs and devices. To fall within the scope of the draft guidance, CPGs must meet the Institute of Medicine’s standards for CPG ‘tustworthiness’…

Click on the link below to read the rest of the Hogan Lovells briefing.

Sign in or Register to continue reading this article

Sign in


It's quick, easy and free!

It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.

Register now

Why register to The Lawyer


Industry insight

In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.


Market intelligence

Identify the major players and business opportunities within a particular region through our series of free, special reports.


Email newsletters

Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.

More relevant to you

To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.

Briefings from Hogan Lovells

View more briefings from Hogan Lovells

Analysis from The Lawyer

View more analysis from The Lawyer


Atlantic House
Holborn Viaduct

Turnover (£m): 1,098.00
No. of lawyers: 2,313 (UK 200)
Jurisdiction: UK
No. of offices: 8
No. of qualified lawyers: 219 (International 50)
No. of partners: 56