FDA finalises guidance regarding sponsor-FDA agreements on trials

The United States (US) Food and Drug Administration (FDA) has finalised guidance on the special protocol assessment (SPA), which is the process by which sponsors of pharmaceutical or biologic applications can meet with the FDA to discuss the design and size of certain clinical or animal studies to determine if they can adequately support marketing approval.

The 30-page guidance includes information regarding the procedures for submitting an SPA request, the content necessary to make such a request, FDA’s assessment process, what happens if the FDA and the sponsor do not agree on trial protocols and when changes can be made to SPA agreements.

An SPA agreement indicates agreement by the FDA with the adequacy and acceptability of specific critical elements of the overall protocol design for a study that is intended to support a future marketing application. The feedback on the issues provides the greatest benefit to sponsors in planning late-phase development strategy. However, the guidance notes that an SPA agreement does not indicate FDA concurrence on every protocol detail.

The guidance states that after completing the SPA review, the FDA will issue a letter which includes comments from the review team, agreement or nonagreement with the proposed protocol, and answers to the sponsor’s relevant questions. Sponsors should be aware that despite additional communications in writing and/or additional Type A or biosimilar biological product development (BPD) Type 1 meetings, sponsors and the FDA may not reach agreement on all aspects of the protocols and specific questions posed.

To read the finalised SPA guidance from the FDA, please click here.