Sonus EchoGen
Executive Summary
FDA requests additional information regarding NDA for the ultrasound contrast agent in a Feb. 25 letter. Agency has requested manufacturing information, including chemistry and analytical methods validation, and re-analysis of some animal and clinical data...
FDA requests additional information regarding NDA for the ultrasound contrast agent in a Feb. 25 letter. Agency has requested manufacturing information, including chemistry and analytical methods validation, and re-analysis of some animal and clinical data.... |