ARTICLE | Politics & Policy
FDA releases timeline for PDUFA V implementation
November 28, 2012 1:56 AM UTC
FDA will publish by the end of 2013 a draft plan to develop and implement a structured benefit-risk assessment for NDAs, according to a list of deadlines for PDUFA V implementation that the agency released on Tuesday. FDA also said it will publish an interim assessment of the new program for enhanced review transparency and communication for NDAs and BLAs by March 31, 2015. ...