Category Archives: Drug Safety Information Podcasts

FDA issues alert on potential dangers of unproven treatment for multiple sclerosis

The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

FDA proposal aims to help reduce unnecessary radiation exposure for children

Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.

FDA permits marketing of a new device for abdominal surgery

On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery.

The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.