ECHO THERAPEUTICS, INC. Echo Therapeutics, Inc. announced that it has submitted a pre-submission package to the U.S. Food and Drug Administration (FDA) for the Symphony CGM System for use in the hospital critical care environment. In conjunction with the pre-submission package, the Company has requested a meeting with the FDA to work cooperatively on the clinical and regulatory plan to support FDA approval of the System. The pre-submission documentation has been submitted to the FDA in order to obtain the Agency's guidance regarding the U.S. regulatory pathway for Symphony, the proper approach to refining the pivotal trial protocol and endpoints, and preparing the pre-marketing application.
The FDA's Pre-Submission Program is intended to allow applicants the opportunity to obtain targeted FDA feedback in response to specific questions related to product development, including planned non-clinical evaluations, proposed clinical study protocols, or data requirements, prior to making a submission to the Agency.
