• Regulatory NewsRegulatory News

    28 Days Later: FDA's Clinical Endpoint to Stop the Horror of Complicated Abdominal Infections

    New guidance issued by the US Food and Drug Administration (FDA) is intended to make it easier for pharmaceutical companies to develop drugs to treat "complicated" intra-abdominal infections (cIAIs), with a goal of achieving a successful outcome within 28 days of a patient starting treatment. Thinking About Development Questions The final guidance document, Complicated Intra-Abdominal Infections: Developing Drugs for Treatment , is an update to a 2012 draft g...
  • FDA Releases Draft Guidance on Abdominal Infection Products

    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to the development of new pharmaceutical therapies for the treatment of complicated intra-abdominal infections (cIAIs), clinically common infections encompassing a wide swath of types of bacteria and locations. These infections are frequently diagnosed as intra-abdominal abscesses, perforations of the stomach or intestine, peritonitis, appendicitis with perforations or peria...