Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared on LinkedIn:
“What can we learn from experiences using real world data (RWD) and real world evidence (RWE) for regulatory decisions by FDA?
RWD and RWE are widely used for descriptive information and strategic decisions within Pharma and Biotech but truly transformative impact is within regulatory strength use of data. With rise in artificial intelligence tools (AI), gathering of regulatory strength RWD and RWE is likely to rise so deep understanding of experiences with FDA is of growing interest to drug development community.
Especially for those focusing on rare diseases and oncology indications where established standard of care critically informs comparative needs.
Few days ago freshly posted table is a great resource summarizing studies in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011. These include, but are not limited to, product approvals, labeling changes, and assessments that determined no regulatory action was warranted.”
More posts featuring Tanja Obradovic on OncoDaily.