Industry and patient groups urge FDA to revise master protocol guidance

Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for drugs and biologics. They argue the current version does not fully address practical concerns and could be improved.

Two industry associations specifically called for greater alignment of the guidance with the approaches used by regulators in other countries, seeking a more globally harmonized framework. Meanwhile, a coalition representing clinical trial sites raised questions about how the guidance would work in day to day site operations.

The comments reflect a broader push from stakeholders to ensure that master protocol designs are both scientifically robust and operationally feasible as the FDA finalizes its guidance.