WILEX, IBA reports pre-BLA meeting with FDA concerning Redectane

06/19/2011 | Medical News Today

WILEX and Ion Beam Applications said it has concluded a prebiologic license application meeting with the FDA concerning PET/CT agent Redectane. WILEX received a special protocol assessment from the agency regarding the design of a Phase III trial of the agent, which would seek to determine whether Redectane with PET/CT performs better than CT alone in diagnosing renal masses. The FDA also asked WILEX to submit process validation data for the third production procedure of the drug as part of the BLA process.

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