FDA Moves to Fast-Track C. diff Treatments

The FDA has proposed a regulation that would fast-track potential treatments for C. diff, calling the infection a serious public health threat.

The proposed rule would enact a provision of the Food and Drug Administration Safety and Innovation Act of 2012 known as Generating Antibiotic Incentives Now, or GAIN. The provision allows fast-tracked review of antibiotics and antifungal drugs designed to treat especially dangerous pathogens. It would also extend the market exclusivity of these drugs by five years.

C. diff is one of 18 pathogens that have been identified for GAIN inclusion.

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