Off-Label Questions, Online: FDA Explains How To Handle Them
This article was originally published in The Gray Sheet
Executive Summary
FDA draft guidance weighs in on web communications, saying that firms must answer off-label-information questions privately, even if the questions arise in a public online forum.
You may also be interested in...
FDA Draft Guidance Extends Reprint Policy To Medical Reference Texts, Clinical Practice Guidelines
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.
Warning For Facebook “Likes” Reflects FDA Social Media Approach
FDA is revealing its views on social media use through individual enforcement actions and provisions in disparate guidances, in the absence of issuing an overarching guidance. A recent warning letter sheds light on the agency’s view of “liking” something on Facebook.
Warning For Facebook “Likes” Reflects FDA Social Media Approach
FDA is revealing its views on social media use through individual enforcement actions and provisions in disparate guidances, in the absence of issuing an overarching guidance. A recent warning letter sheds light on the agency’s view of “liking” something on Facebook.