FDA releases PDUFA VI program report on combination products
A new independent report on the FDA’s review practices for combination products under the Prescription Drug User Fee Act (PDUFA VI) gives the agency generally positive marks but finds room for refinements in communication and technology to improve the pre-submission and review process.
The report, commissioned by FDA as part of its PDUFA VI commitments, was conducted by Eastern Research Group and looked at FDA staff and sponsor experiences with combination products reviews during the pre-request for designation (pre-RFD), RFD, inter-center consult request (ICCR) and application submission stages.
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