USA – Combination products: FDA releases PDUVA VI program report

A new independent report on the US Food and Drug Administration’s (FDA) 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.
FDA first detailed its pre-RFD program in draft guidance in 2017 before finalizing the guidance the following year. The pre-RFD process is intended to allow combination product sponsors a flexible, informal way to get feedback about the identity or classification of a medicinal product before engaging in the formal RFD process. (RELATED: FDA offers draft guidance on new pre-request for designation processRegulatory Focus 12 January 2017).
According to the report, sponsors and FDA staff found the pre-RFD and RFD processes to be generally “effective and efficient despite some challenges.” Sponsors greatly preferred the pre-RFD route, with 46 pre-RFD and 3 RFD reviews completed during the review period…