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  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Antibacterial Therapies for Unmet Needs

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance first drafted in 2013 to assist sponsors in the development of new antibacterial drugs for the treatment of serious bacterial diseases in patients with an unmet medical need. "After consideration of comments received in response to the draft guidance, FDA updated the guidance to include clarifications about trial designs for streamlined development programs and statistical approaches," the age...
  • Extensive New Guidance Explains FDA's Recommendations for Streamlined Antibiotic Development

    A new draft guidance document released by the US Food and Drug Administration (FDA) provides extensive recommendations regarding the streamlined development of antibacterial products for patients with untreatable, serious infections. Background The draft guidance, released 1 July 2013, comes just as FDA is giving renewed attention to antibacterial products under the new Generating Antibacterial Incentives Now (GAIN) Act, a piece of legislation that was bundled into th...
  • Waxman Introduces New Bill to Require Data Collection, Monitoring by Antibiotics Industry

    • 18 October 2012
    • By
    Representative Henry Waxman (D-CA), the ranking member on the House Energy and Commerce Committee, is preparing to introduce legislation that would increase the amount of information required of manufacturers who produce antibiotics for use in animals. The legislation would require the US Food and Drug Administration (FDA), which recently released an advanced notice of public rulemaking on the topic of antibiotic monitoring and use, to "increase information on the am...
  • FDA Releases Draft Guidance on Abdominal Infection Products

    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to the development of new pharmaceutical therapies for the treatment of complicated intra-abdominal infections (cIAIs), clinically common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...