The US Food and Drug Administration (FDA) has recently rejected new antibiotics for common infections citing the requirement that the drugs intended to treat non-serious infections prove superior to placebo rather than active controls. With the introduction of more stringent statistical criteria, inconsistencies in bacterial-susceptibility testing and renewed debate over placebo-controlled testing in antibiotic trials, how much is the regulatory regime deterring investment in the sector?

The pharma company view

The biotech company view