The Generating Antibiotic Incentives Now (GAIN) Act of 2011 (H.R. 2182) seeks to create incentives to encourage the development of products to treat, prevent, detect and diagnose antibiotic-resistant infections. It extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotics.
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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after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.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 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.
More info"As a nation, we need to exercise greater care with our use of antibiotics, in both humans and animals, so that these medications remain effective in treating serious bacterial infections."
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