FDA Releases Draft Guidance for Industry On Distributing New Drug Risk Information

The Food and Drug Administration June 6 released a draft guidance for industry on distributing scientific and medical publications that contain new risk information for approved prescription drugs and biologics.

The FDA said it recognizes that the safety profile of a drug product evolves throughout its lifecycle as more people use it, and it can be helpful for health-care practitioners to receive new risk information about an approved product in a timely manner. However, if the new information is unreliable or presented without the appropriate context, it could influence prescribing decisions or patient monitoring in a way that could harm ...