FDA draft guidance on distributing articles about unapproved drug/device uses.(Regulatory Update)

Publication: Research Practitioner

Bookmark this article Print this article Link to this article Email this article Digg It! Add to del.icio.us RSS

COPYRIGHT 2008 A Thomson Healthcare Company

In the February 20, 2008, Federal Register, FDA announced the availability of a draft guidance document for industry titled Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on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. The draft guidance provides drug, biologic, and device manufacturers with FDA's views on...

Read the full article for free courtesy of your local library.