New FDA Performance Goals Under PDUFA II

The big emphasis in the US industry/Food and Drug Administrationnegotiations over the Prescription Drug User Fee Act reauthorization was on the Investigational New Drug phase, Murray Lumpkin, deputy Center director at the FDA's Center for Drug Evaluation and Research, told the US Nonprescription Drug Manufacturers Association's annual research and scientific development conference.

While most of this phase is in corporate hands, there are things that can be helped by agency/industry interaction, he said.

PDUFA II, which refers back to the original law and makes some changes, requires the FDA to do some tracking, write guidances and notice-and-comment rulemaking and perform on-going refining. A double-tracking system has been introduced for working through original New Drug Applications submitted and for efficacy supplements filed.