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