1.2 Topics of DiscussionThe purpose of the morning session of...

1.2 Topics of DiscussionThe purpose of the morning session of this Advisory Committee meeting is to discuss the product attributes of remestemcel-L and their relation to product quality and effectiveness.

The Applicant has defined critical quality attributes (CQAs) for remestemcel-L that are proposed to be related to the potency and activity of the product (see Section 5.1 Critical Quality Attributesin the Applicant’s briefing document).

FDA’s position is that the product attributes the Applicant has identified as related to potency and activity, however, do not have a demonstrated relationship to the clinical performance of specific DP lots, and that the product’s proposed immunomodulatory mechanism of action has not been demonstrated in vivo in study subjects receiving remestemcel-L. Without a demonstrated relationship with clinical effectiveness and/or in vivo potency/activity, controlling these CQAs may not be sufficient to ensure the manufacturing process consistently produces remestemcel-L lots of acceptable quality.

https://www.fda.gov/media/140988/download