GPhA Warns FDA On ANDA Review Transparency

User fee negotiations could be 'lengthy and very detailed' unless FDA does 'the right thing' and implements 'effective' communication practices, generic trade group says.

Communications improvements may wind up the most important issue in the generic drug user fee reauthorization, gaining more prominence than problems with ANDA approvals.

In written comments submitted following a June public hearing to kick-off the GDUFA II process, the Generic Pharmaceutical...