EchoGen to bypass MIDAC meeting
Sonus Pharmaceuticals has announced that the Food and Drug Administration will not require a Medical Imaging Drug Advisory Committee (MIDAC) meeting to complete the review of the Bothell, WA-based company's EchoGen ultrasound contrast agent. In reaching
Sonus Pharmaceuticals has announced that the Food and Drug Administration will not require a Medical Imaging Drug Advisory Committee (MIDAC) meeting to complete the review of the Bothell, WA-based company's EchoGen ultrasound contrast agent. In reaching its decision, the FDA indicated that it was comfortable with the general issues regarding the class of products including ultrasound contrast agents, according to the company.
The comfort level apparently evolved out of a Radiology Device Advisory Committee meeting held earlier this year for FS069 (now Optison), an ultrasound contrast agent from Molecular Biosystems (SCAN 3/5/97). The ruling bypassing the need for an advisory committee meeting was exclusive to EchoGen, however, said Kelly Ford, communications director for Sonus. Officials at Molecular Biosystems were unavailable for comment. Sonus would not speculate on how much time the FDA's decision would cut off EchoGen's review time.