Home » FDA Considering Expanded Communication With Drugmakers During Reviews
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
Drug Industry Daily
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