Home » DeLauro: FDA Shouldn’t Consider Outsourcing Antibiotic Reviews
DeLauro: FDA Shouldn’t Consider Outsourcing Antibiotic Reviews
Rep. Rosa DeLauro (D-Conn.) is
objecting to the FDA’s decision to consider outsourcing reviews of labeling updates for approved antibiotics in
a letter to FDA Commissioner Margaret Hamburg. The move won the support last month of the agency’s Anti-Infective Drugs Advisory Committee, which
met to clarify the implementation process for the June 2009 guidance on labeling for susceptibility
test information for antimicrobial drugs.
Drug Industry Daily
Drug Industry Daily
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