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Guiding Without Guidance

 
• By Kate Rawson

Higher regulatory approval standards are hard enough for antimicrobial sponsors; but a lack of formal guidelines from FDA has made drug development particularly challenging.

The thorniest regulatory problem in antibiotic drug development isn’t necessarily that the approval bar at the Food & Drug Administration is getting higher, but the fact that FDA has yet to establish formal guidelines on the process. The resulting "catch-as-catch can" regulation, executives say, makes it exceedingly difficult to develop new drugs.

FDA has been developing a series of antibiotic guidance documents for at least five years. Since November 2002, five documents...

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