US FDA allows companies to distribute articles on off-label use
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has finalised controversial guidance that permits drug and medical device manufacturers to disseminate information to healthcare professionals on the off-label uses of their approved products by reprinting articles in medical and scientific journals1,2. The document contains recommendations outlining the approach that the agency wants companies to follow in printing and distributing such articles.
You may also be interested in...
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.