Accelerated Approval: Former ODAC Member Sekeres Reflects On Avastin Withdrawal
Executive Summary
Leukemia specialist Mikkael Sekeres’ new book, “Drugs and the FDA: Safety, Efficacy, and the Public’s Trust,” serves two purposes: a history of FDA oversight and regulation of drugs, as shaped by various public health crises and tragedies; and an insider's account of the June 2011 hearing on withdrawal of Avastin’s accelerated approval in breast cancer.