Antibiotic Guidance: Limited Populations Do Not Include Rare Infections
US FDA draft guidance on Limited Population Antibacterial Drug pathway says eligibility considerations for preventative products will center on size of population receiving drug, not incidence of infection.
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US FDA Clarifies Populations And Anti-Infective Indications Eligible For Approval Under LPAD
Final guidance on regulatory pathway for antibacterial and antifungal drugs is not substantially different from 2018 draft version but gives more detail on the process for submitting promotional materials prior to dissemination and seeking termination of LPAD labeling limitations.
US FDA's Antimicrobial Head Ed Cox Leaves For Regeneron; Agency Needs New LPAD Champion
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 Stakeholders Discuss Ethics Of Testing Limited Population Drugs In Broader Populations
The US FDA's LPAD draft guidance suggests that clinical trials for potential limited population antibacterials would enroll broader patient populations. But is that an ethical approach?