Food & Drug Administration

FDA streamlines medical device voting process

FDA expert panels plan to change the way they review and discuss data during public hearings regarding medical devices being considered for premarket approval. Effective May 1, 2010, medical device advisory committees will vote on the safety, effectiveness and risks vs. benefits of devices for which premarket approval applications have been submitted. In the past, [...]

GE’s misleading drug claims

The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has reviewed GE Healthcare’s Web site for its contrast agent, Visipaque (iodixanol) Injection, and deemed the promotional material “misleading because it presents unsubstantiated comparative claims and omits and minimizes the risks associated with Visipaque.” Therefore, the agency sent a letter to GE, stating that it [...]

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