Safety of Import Drugs Is Focus of Next PDUFA Reauthorization

The FDA plans to use funding from the next reauthorization of the Prescription Drug User Fee Act (PDUFA) to address recent challenges in regulating drug safety, especially monitoring products manufactured abroad.

“I would say we still don’t have a sophisticated drug safety system, but we’re on the way to building one,” Janet Woodcock, director of the Center for Drug Evaluation and Research, said at a recent FDA public meeting.

Joshua Sharfstein, the FDA’s principal deputy commissioner, said the meeting was the first step in the reauthorization process, which could take more than two years. He added that the PDUFA reauthorization should be used to focus on “processes that can identify serious risks earlier.”
Drug GMP Report