USA: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices

This draft guidance describes the Food and Drug Administration’s current thinking on recommended practices for drug manufacturers and their representatives to follow if they choose to distribute to health care professionals or health care entities scientific or medical journal articles that discuss new risk information for approved prescription drugs marketed in the United States.
The recommendations in this draft guidance are intended to address issues specific to the distribution of new information about risks associated with a drug that further characterizes risks identified in the approved labeling of drugs intended for human and animal use (FDA Daily Digest Bulletin, 6 June 2014).
Click here to download the guidance for industry (95 kB).

This item is also included in our monthly overview, the NVC Members-only Update. If you have any questions, please contact us: info@nvc.nl, +31-(0)182-512411.