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September 5, 2012

The Safety Risks of Innovation: The FDA's Expedited Drug Development Pathway

JAMA. 2012;308(9):869-870. doi:10.1001/jama.2012.9658

Driving Biomedical Innovation” is one of the signature initiatives of the Obama Administration and of US Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg's tenure at the agency.1 This initiative embodies administration policies that government should encourage growth and innovation rather than being the stifling blanket of bureaucracy and delay so often cited by critics of government regulation. Prominent in the agency-wide initiative is the FDA's program for speeding approval of seemingly promising new drugs, known officially as the “Expedited Drug Development Pathway.”1