New path for antibiotic approvals?
Congress will consider a new drug approval pathway in an effort to encourage development of critically needed, lifesaving antibiotics as part of a strategy to address the public health crisis of antibiotic resistance, the Infectious Diseases Society of America said. The society proposed the new pathway to help streamline approval of new antibiotics for serious infections where few or no treatment options currently exist. The proposed mechanism would enable pharmaceutical companies to study "Special Population Limited Medical Use" drugs in far fewer patients than currently is required, more rapidly, and at significantly less cost. The drugs would be reserved for use in specific patient populations that lack other treatment options, and would include warnings designed to encourage prudent use and slow the development of resistance, according to the society.
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|Title Annotation:||POLICY & PRACTICE|
|Publication:||Internal Medicine News|
|Date:||Apr 1, 2012|
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