14 Submissions with RWE in FY 2023: FDA

FDA says it received 14 submissions to CDER in FY 2023 that contained real-world evidence (RWE). An online statement, provided to fulfill a PDUFA 7 commitment, says 10 of the submissions were for IND protocols and four were for NDAs or BLAs.

For the protocols, the post says, nine of the 10 involved safety, and the last one was on effectiveness. Six of the submissions were to satisfy a post-marketing requirement and four satisfied a post-marketing commitment.

For the NDAs/BLAs, the primary focus of three of submissions was effectiveness and the fourth focused on safety. Two of the submissions were intended to support the demonstration of safety and/or effectiveness for a product not previously approved by FDA and two were to support labeling changes for an approved product.

In FY 2023, the post says, approval was given to Genentech’s Actemra (tocilizumab) and UCB’s Vimpat (lacosamide) based at least in part on RWE.