Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules

Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be sufficient for drug and biologic approvals.

Commenters, however, are divided on how much flexibility the agency should allow in applying this evidentiary standard. Some argue for a more permissive approach to accelerate access, while others caution that too much leeway could compromise the robustness of the approval process.

The feedback also includes requests for additional clarification on specific criteria and implementation details, indicating that stakeholders want clearer guidance before the policy is finalized.

Overall, the discussion reflects a balance between encouraging innovative therapies and maintaining rigorous evidence standards for safety and efficacy.