3 March 2017 - Despite some improvements, drug makers say the US FDA has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office.

Specifically, Government Accountability Office (GAO) says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Administration Safety and Innovation Act of 2012, but roughly half of those guidances remain in draft form.

GAO also says that FDA has yet to provide guidance to sponsors on how to navigate the GAIN Act's main incentives.

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