Eyeing Antibiotics, Drugmakers Ask For Longer Pathogen List

Law360, New York (August 12, 2013, 4:24 PM EDT) -- The U.S. Food and Drug Administration is facing pressure to expand its new list of pathogens that could seriously threaten public health, as drugmakers developing antibiotics position themselves to qualify for streamlined approval and extra exclusivity, according to letters submitted to the agency by Monday's deadline.

In comments on a proposed rule, manufacturers such as Genentech Inc. and Viamet Pharmaceuticals Inc., as well as nonprofits and a member of Congress, urged the FDA to consider a more inclusive approach to its list of qualifying pathogens....
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