FDA Updating Antibiotic Guidances, But Is It Too Late For Some Sponsors?
• By Becky Jungbauer
It was supposed to be a year with a wealth of novel antibiotics, but regulatory concerns turned 2008 from a year of banner antibiotic approvals into a sizeable crop of action letters. Now the delays are taking a serious toll, causing some sponsors to drastically restructure in the face of uncertain and evolving regulatory standards
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