Throckmorton: PDUFA Meetings With Industry to End by January

As the FDA continues its negotiations in advance of the reauthorization of the Prescription Drug User Fee Act (PDUFA), the agency’s timeline for completing the process is coming into focus. The agency intends to wrap up its discussions with drugmakers and other stakeholders by January and then begin consulting with HHS on a proposal to be made public by mid-2011, Douglas Throckmorton, deputy director of CDER, said at the Regulatory Affairs Professionals Society annual meeting this week.
Drug Industry Daily