LPAD Approval Pathway Is Not Saving Antimicrobial Development
US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations.
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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.