The US Food and Drug Administration (FDA) on Tuesday provided updates on two programs negotiated under the Prescription Drug User Fee Act (PDUFA VII) meant to give sponsors an opportunity to engage the agency early and spur innovation. The programs address the use of real-world evidence (RWE) to support product effectiveness or to meet post-approval study requirements and implementing innovative clinical trial designs.
In a Federal Register notice, FDA said it will start accepting applicants into its new Advancing Real-World Evidence Program. While the agency has long touted the potential of using RWE to ensure the safety and efficacy of products, the program is specifically aimed at understanding how that can be achieved. Regulators said the intent of the program is to “improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims, including approval of new indications of approved medical products or to satisfy post-approval study requirements.” (RELATED: Industry lauds PDUFA VII focus on innovation, transparency, Regulatory Focus 26 August 2022)…
