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The US FDA's LPAD draft guidance suggests that clinical trials for potential limited population antibacterials would enroll broader patient populations.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?
You may also be interested in...
Cormedix prepares NDA submission for Neutrolin for prevention of catheter-related blood stream infections, aiming to become the third approval under the US FDA’s Limited Population Pathway.
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.
US FDA draft guidance on Limited Population Antibacterial Drug pathway says eligibility considerations for preventative products will center on size of population receiving drug,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.