Biofield in discussions with FDA
Biofield is in discussions with the Food and Drug Administration over the protocol for a proposed limited confirmation study that would complement the company's application for premarket approval (PMA) of its Alexa 1000 breast cancer diagnostic system.
Biofield is in discussions with the Food and Drug Administration over the protocol for a proposed limited confirmation study that would complement the company's application for premarket approval (PMA) of its Alexa 1000 breast cancer diagnostic system. The FDA had previously asked Atlanta-based Biofield to resubmit its PMA, due to deficiencies in the design of the multicenter clinical trials intended to support the submission (SCAN 3/19/97).
The proposed confirmation study is expected to include no fewer than 300 to 400 patients with previously identified breast lesions, according to the company. Assuming the successful outcome of the confirmation study, Biofield intends to rely upon its original clinical trials of more than 1200 women to demonstrate safety, efficacy, and clinical utility.
Upon completion of the discussions to establish protocol for the limited confirmation study, Biofield will evaluate its options and finalize its plans for proceeding. If the company decides to go ahead with the proposed study, the enrollment phase of the study is expected to take several months, followed by data analysis. The PMA, once accepted for filing by the FDA, will continue to be regulated under expedited review, according to Biofield.
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