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IDSA Proposes New Pathway For Antibiotic Approval
Date:3/8/2012

les pharmaceutical companies to study SPLMU drugs in far fewer patients than currently is required, more rapidly, and at significantly less cost – because they are intended for more targeted use within a special population of patients who lack other treatment options. SPLMU designation reserves a drug for use in specific populations in which the benefits outweigh the risks, and encourages prudent use of the drug to slow the rate of resistance.

"The proposed SPLMU drug approval mechanism will bring critically needed innovation to the anti-infective pipeline, encouraging antibiotic development and lowering the hurdles to getting these critically needed drugs to patients who desperately need them," said Robert Guidos, vice president of public policy and government relations at IDSA. "In addition, we've designed it to foster antimicrobial stewardship, so these drugs will be used only when appropriate, extending their lifesaving power."

To read the rest of this press release, click here: www.idsociety.org/New_Pathway_for_Antibiotic_Approval/.


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SOURCE Infectious Diseases Society of America (IDSA)
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