US drug sponsors' regulatory experience was mixed during PDUFA IV, says Tufts CSDD

Drug sponsors experienced a mixed regulatory burden under the Food and Drug Administration Amendments Act, which was also the fourth iteration of the Prescription Drug User Fee Act (PDUFA IV), according to new research from the USA-based Tufts Center for the Study of Drug Development.

The analysis found that, since 2007, the regulatory burden decreased for New Drug Applications (NDA) and Biologics License Applications (BLA) approvals, but increased for supplemental NDAs and biologics license approvals (sBLA), while regulatory outsourcing by sponsors also increased.

Tufts CSDD conducted the research in advance of ongoing Congressional deliberations on reauthorizing the Prescription Drug User Fee Act (PDUFA) for another five years. Drug sponsors have been paying user fees to the FDA since enactment of PDUFA in 1992.