The ISSCR Comments on Draft Guidance from FDA - Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products

The ISSCR shared comments on draft guidance from the FDA's Center for Biologics Evaluation and Research (CBER) (Docket No. FDA2021-D-1146) Real-World Data: Assessing Registries to Support Regulatory Decision Making for Drug and Biological Products.

Among other points, the ISSCR stressed that."...any regulatory submission that is reliant on registry data must be held to the current standard that requires robust and rigorously analyzed data to demonstrate the safety and effectiveness of new products."

The Society also expressed concern that unscrupulous businesses seeking to prematurely commercialize stem cell-based interventions may seek to use substandard outcome measures to claim that their products are safe and effective. The ISSCR has commented previously that these businesses have abused government databased to appear legitimate and to promote their treatments to patients.

Read the letter.