This article was originally published in The Gray Sheet
Infectious disease imaging agent's FDA premarket submission remains deficient after about three years under agency review, the firm states Nov. 29 following FDA notification. The agent is intended for use in detecting and diagnosing osteomyelitis (bone infection). The agent's biologic license application shortcomings "do not involve safety or manufacturing matters, but readings made by independent (blinded) readers," Immunomedics explains
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