Accelerated Approvals

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic...

Drug Supply Chain Security Act (DSCSA)

  Sign up for Drug Supply Chain Security Act email updatesThe Drug Supply Chain Security Act (DSCSA) outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply...

Rezafungin Injection

Exceptions or additions to the recognized standards Minimum Inhibitory Concentrations(mcg/mL)Disk Diffusion(zone diameters in mm)PathogenSIRSIRCandida albicans≤0.12–≥13–Candida glabrata≤0.12–≥ 15–Candida parapsilosisM27M44S supplement is...