• Regulatory NewsRegulatory News

    LPAD pathway: FDA finalizes guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.   The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited ...
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    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 "After consideration of comments received in response to the draft guidance, FDA updated the guidance to include clarifications about trial designs for streamlined development programs and statistical approaches," the age...
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    Experts Call for New Regulatory Pathways for Antibiotics

    Faced with the increasing threat of antimicrobial resistance (AMR), experts are calling for more incentives to boost investment in new antibiotics. At the FDA/CMS Summit in Washington, DC today, representatives from several companies developing new antibiotic treatments said that while recent initiatives such as the Generating Antibiotics Now Act (GAIN Act) have helped revitalize investment in antibiotic development, more needs to be done to encourage research and deve...