Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I

27 Oct 2016

Industry dismay at slow pace of ANDA approvals and FDA communications in early years of first user fee agreement factored into GDUFA II negotiations.

Participants in negotiations to renew the generic drug user fee agreement had to overcome industry's "buyer's remorse" following complaints about FDA's early implementation of ANDA approval and communication provisions in the first Generic Drug User Fee Act (GDUFA I) program.

At the same time, negotiators had to address FDA's logistical limitations and concerns about the quality of initial ANDA submissions,...