Is uncertainty concerning the regulation of antimicrobial drug trials stifling investment in infectious disease treatments? Here, experts from a large pharma company and a biotech firm provide their perspectives.
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?
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Brenner, R., Ellis-Grosse, E. & Echols, R. Moving goalposts—regulatory oversight of antibacterial drugs. Nat Biotechnol 24, 1515 (2006). https://doi.org/10.1038/nbt1206-1515
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