FDA Considering Expanded Communication With Drugmakers During Reviews

The FDA is considering allowing its project managers to communicate directly with drugmakers during the review process for a new product. The increased communication, which was proposed during a recent Prescription Drug User Fee Act (PDUFA) reauthorization meeting, would take place during the 30 days immediately following the agency’s internal mid-cycle meeting, the FDA says in notes of a Dec. 13 PDUFA meeting posted on its website recently. “This communication would serve as a status update for the sponsor and could also be used to communicate any high-level deficiencies that were discussed at the internal mid-cycle meeting,” the agency says.
Drug Industry Daily