Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
More infoSenator Dianne Feinstein (D-CA) today introduced the Preventing Antibiotic Resistance Act, a bipartisan bill that would eliminate certain antibiotic-related practices that contribute to the rise of drug-resistant bacteria and endanger human health. The legislation is co-sponsored by Senators Susan Collins (R-ME), Kirsten Gillibrand (D-NY), Jack Reed (D-RI), Barbara Boxer (D-CA) and Maria Cantwell (D-WA).
More infoThis bibliography lists the latest published scientific and economic literature concerning the contribution of routine antibiotic use in food animals to the growing public health crisis of human antibiotic resistance. Research on how antibiotic use in food animal production contributes to the growing health crisis of antibiotic resistance dates back more than 30 years.
More infoAs multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.
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