4:04 PM
Apr 13, 2018
 |  BC Extra  |  Politics & Policy

FDA issues final guidance on SPAs

Editor's Note: This article was updated on Apr 16, 2018 at 12:48 PM PDT

FDA published its final guidance Friday on procedures and policies for obtaining an SPA agreement, which clarifies a few details from the 2016 draft guidance on the topic (see BioCentury Extra, May 3, 2016).

The final guidance adds language stating that the agency should communicate with sponsors about issues with a protocol before sending a no SPA agreement letter.

The final guidance removed a line from the 2016 draft guidance that stated the "absence of an FDA comment on a particular aspect of the trial does not necessarily indicate agreement on that aspect if the sponsor did not specifically ask about it." Instead, the final guidance says that "claims not agreed upon at the meeting, and not supported by appropriate prespecified objectives and appropriate control for multiplicity are unlikely to support inclusion in labeling."

For clinical trials, the document says sponsors should outline how a proposed protocol will help evaluate biosimilarity or interchangeability, if that is an intended goal. For a preclinical study using animal models to test efficacy, the final guidance says sponsors should include focused questions about the plan to ensure data quality and integrity.

The document clarifies that sponsors should aim to submit SPA requests with enough time to allow FDA to complete its assessment before the protocol is submitted to an IRB. Sponsors should also reference prior relevant discussions and agreements with FDA in their SPA request. Furthermore, the guidance says it would be appropriate to discuss whether one trial is sufficient to support approval at an end-of-phase II meeting with FDA, before submitting an SPA, since the SPA focuses on the submitted protocol rather than the bigger regulatory question of how many trials are sufficient.

According to the final guidance, any FDA advisory committee discussion of protocols submitted for an SPA will generally not be open to the public.

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