Antibiotic Test Case: Will LPAD + Non-Inferiority = Approval For Plazominicin's BSI Indication?
US FDA Office of Antimicrobial Products Director Ed Cox explained to an advisory committee why a non-inferiority analysis could work in the context of an unmet need.
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Long-time deputy John Farley becomes acting director of the Office of Antimicrobial Products. Cox, who served as the director of the office for more than a decade, joins Regeneron to serve as vice president of regulatory affairs.
Antibiotic sponsors wonder whether RWE would be sufficient to convert a product to full approval. Ahead of US FDA's public meeting on the LPAD guidance, industry has a number of lingering questions.
Achaogen can take solace in US FDA's approval of the aminoglycoside antibacterial for the treatment of complicated urinary tract infections, but the limited use indication for bloodstream infections was rejected.