Compliance

Category

When Off-Label Use Becomes a Problem

Australian food and drug regulators are investigating Medtronic and the selling of a controversial product, Infuse Bone Graft, without a safety component necessary for compliance. The Minnesota-based medical device giant denies the product was pulled due to compliance...

Australia TGA Plans GCP Inspection Program

Australia’s Therapeutic Goods Administration (TGA) plans a GCP inspection program to support Australia’s position as a high quality worldwide hub for clinical research.  TGA is Australia’s regulatory body for therapeutic goods (medicines, medical devices, gene...